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Data / Medical devices / United States / MEDLINE INDUSTRIES, LP - Northfield

MEDLINE INDUSTRIES, LP - Northfield: FDA-registered device maker in Northfield, IL, United States, 357 510(k) clearances

MEDLINE INDUSTRIES, LP - Northfield is registered with the FDA (registration 1417592) in Northfield, IL, United States. It lists 618 device types. The FDA files 357 510(k) clearances under its listings, the newest dated March 25, 2026. 249 recall events name it as the recalling firm (29 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch MEDLINE INDUSTRIES, LP - Northfield
FDA registration number
1417592
Address
Three Lakes Drive, Northfield, IL, United States, 60093
Owner or operator
Medline Industries, LP (1417592)
Roles
Complaint file establishment, Repackager or relabeler, Specification developer
First device listed
December 29, 1977
Registered through
2027
Brand names listed
"Salt Airway S.A.L.T.", 137075-Surgical SetUp CSTM, 145666-Dressing Change CSTM, 171415-O.R. KIT CSTM, 946240-Skin Prep CSTM, A10 Low-air-loss Mattress System, ABDOMINAL BINDER, ACCU-SORB and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Specification developeraccessdata.fda.gov
Accessories, ArthroscopicNBH1Complaint file establishment, Specification developeraccessdata.fda.gov
Accessories, Cleaning Brushes, For EndoscopeMNL1Specification developeraccessdata.fda.gov
Accessories, WheelchairKNO1Specification developeraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)JMA1Complaint file establishmentaccessdata.fda.gov
Adaptor, DressingILD1Specification developeraccessdata.fda.gov
Adaptor, HygieneILS1Specification developeraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Specification developeraccessdata.fda.gov
Adaptor, Ureteral CatheterEYI1Specification developeraccessdata.fda.gov
AdenotomeKBH1Specification developeraccessdata.fda.gov
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double SaltKOO1Complaint file establishmentaccessdata.fda.gov
Adult Portable Bed Rails For Medical PurposesQTC1Specification developeraccessdata.fda.gov
Agent, ClearingKEM1Complaint file establishmentaccessdata.fda.gov
Aid, TransferIKX1Specification developeraccessdata.fda.gov
Airway, NasopharyngealBTQ1Specification developeraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Specification developeraccessdata.fda.gov
Alarm, Conditioned Response EnuresisKPN2Complaint file establishmentaccessdata.fda.gov
AmniotomeHGE1Specification developeraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Specification developeraccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Specification developeraccessdata.fda.gov
Anesthesia Conduction KitCAZ2Specification developeraccessdata.fda.gov
Anti Fog Solution And Accessories, EndoscopyOCT2Complaint file establishment, Specification developeraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Complaint file establishmentaccessdata.fda.gov
Apparatus, Exhaust, SurgicalFYD2Specification developeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Specification developeraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Specification developeraccessdata.fda.gov
Applicator For Rectal SuppositoryOOW1Specification developeraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Specification developeraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Specification developeraccessdata.fda.gov
Applicator, EntKCJ1Specification developeraccessdata.fda.gov
Applicator, VaginalHGD1Specification developeraccessdata.fda.gov
Applier, Hemostatic ClipHBT1Specification developeraccessdata.fda.gov
Applier, Surgical, ClipGDO1Specification developeraccessdata.fda.gov
Apron, LeadedEAJ1Specification developeraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Specification developeraccessdata.fda.gov
Automated Urinalysis SystemKQO1Complaint file establishmentaccessdata.fda.gov
AwlHWJ1Specification developeraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Complaint file establishmentaccessdata.fda.gov
Bag, IceKYR1Specification developeraccessdata.fda.gov
Bag, ReservoirBTC1Specification developeraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Specification developeraccessdata.fda.gov
Band Or Belt, Pelvic SupportISR1Specification developeraccessdata.fda.gov
Bandage, CastITG1Complaint file establishment, Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Complaint file establishment, Specification developeraccessdata.fda.gov
Bandage, LiquidKMF1Complaint file establishmentaccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Complaint file establishment, Specification developeraccessdata.fda.gov
Bariatric BedOSI2Specification developeraccessdata.fda.gov
Basin, EmesisFNY1Specification developeraccessdata.fda.gov
Bath, Sitz, NonpoweredKTC1Specification developeraccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Specification developeraccessdata.fda.gov
Bed, ManualFNJ1Specification developeraccessdata.fda.gov
Bed, Therapeutic, Ac-Powered, Adjustable Home-UseLLI2Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
BedpanFOB1Specification developeraccessdata.fda.gov
Belt, WheelchairIQB1Specification developeraccessdata.fda.gov
BenderHXW1Specification developeraccessdata.fda.gov
Binder, AbdominalFSD1Specification developeraccessdata.fda.gov
Binder, BreastHEF1Specification developeraccessdata.fda.gov
Binder, ElasticKMO1Specification developeraccessdata.fda.gov
Binder, Medical, TherapeuticMDR1Complaint file establishmentaccessdata.fda.gov
Bistoury, TrachealKCC1Specification developeraccessdata.fda.gov
Bit, DrillHTW1Complaint file establishment, Specification developeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Complaint file establishment, Specification developeraccessdata.fda.gov
Blade, ScalpelGES1Complaint file establishmentaccessdata.fda.gov
Block, Cutting, Ent, Non-SterileNNR1Specification developeraccessdata.fda.gov
Blood Pressure CuffDXQ2Specification developeraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Complaint file establishmentaccessdata.fda.gov
Board, Arm (With Cover), Non-SterileNOD1Specification developeraccessdata.fda.gov
Board, Arm (With Cover), SterileBTX1Specification developeraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Specification developeraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Specification developeraccessdata.fda.gov
Bougie, UrologicalFAX1Specification developeraccessdata.fda.gov
Brace, DrillHXY1Specification developeraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Specification developeraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Complaint file establishmentaccessdata.fda.gov
Burn Kit Without DrugOJJ1Specification developeraccessdata.fda.gov
Cable, ElectrodeIKD2Complaint file establishment, Specification developeraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Specification developeraccessdata.fda.gov
CaliperKTZ1Specification developeraccessdata.fda.gov
Caliper, OphthalmicHOE1Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Specification developeraccessdata.fda.gov
CaneIPS1Specification developeraccessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-DisposableFBM1Specification developeraccessdata.fda.gov
Cannula, EarJYC1Specification developeraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Specification developeraccessdata.fda.gov
Cannula, OphthalmicHMX1Specification developeraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Complaint file establishment, Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Cardiopulmonary Resuscitation Aid KitOEV2Specification developeraccessdata.fda.gov
Carrier, LigatureGEJ1Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Catheter Care TrayOHR2Complaint file establishment, Specification developeraccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Specification developeraccessdata.fda.gov
Catheter, Conduction, AnestheticBSO2Specification developeraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Specification developeraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Complaint file establishmentaccessdata.fda.gov
Catheter, IrrigationGBX1Specification developeraccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Specification developeraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Complaint file establishment, Specification developeraccessdata.fda.gov
Catheter, Retention, Barium Enema With BagFGD2Specification developeraccessdata.fda.gov
Catheter, StraightEZD2Specification developeraccessdata.fda.gov
Catheter, Ureteral, Gastro-UrologyEYB2Specification developeraccessdata.fda.gov
Catheter, UrethralGBM2Specification developeraccessdata.fda.gov
Catheter, UrologicalKOD2Complaint file establishment, Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Specification developeraccessdata.fda.gov
Cement, Stomal Appliance, OstomyEZR1Specification developeraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Complaint file establishmentaccessdata.fda.gov
Chair And Table, MedicalKMN1Specification developeraccessdata.fda.gov
Chair, Adjustable, MechanicalINN1Specification developeraccessdata.fda.gov
Chair, Positioning, ElectricINO2Specification developeraccessdata.fda.gov
Chair, With CastersINM1Specification developeraccessdata.fda.gov
Chemotherapy Spill Clean-Up KitPWT1Specification developeraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Specification developeraccessdata.fda.gov
Chisel, Middle-EarJYE1Specification developeraccessdata.fda.gov
Chisel, NasalKAN1Specification developeraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Specification developeraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Specification developeraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Specification developeraccessdata.fda.gov
ClampHXD1Specification developeraccessdata.fda.gov
Clamp, CircumcisionHFX2Specification developeraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Specification developeraccessdata.fda.gov
Clamp, Ossicle HoldingJYF1Specification developeraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Specification developeraccessdata.fda.gov
Clamp, UmbilicalHFW2Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Specification developeraccessdata.fda.gov
Clip, ImplantableFZP2Complaint file establishment, Specification developeraccessdata.fda.gov
Clip, Removable (Skin)FZQ1Specification developeraccessdata.fda.gov
Clip, VascularDSS2Complaint file establishment, Specification developeraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Specification developeraccessdata.fda.gov
Collector, Urine, Pediatric, For Indwelling CatheterFFH2Specification developeraccessdata.fda.gov
Collector, Urine, Powered, Non Indwelling CatheterNZU1Specification developeraccessdata.fda.gov
Component, CastLGF1Specification developeraccessdata.fda.gov
Components, ExerciseIOD1Specification developeraccessdata.fda.gov
Components, WheelchairKNN1Specification developeraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Repackager or relabeleraccessdata.fda.gov
Connector, Airway (Extension)BZA1Specification developeraccessdata.fda.gov
Connector, CatheterGCD1Specification developeraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Specification developeraccessdata.fda.gov
Container, SharpsMMK2Specification developeraccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Complaint file establishment, Specification developeraccessdata.fda.gov
Container, Specimen Mailer And Storage, SterileKDT1Complaint file establishmentaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishment, Specification developeraccessdata.fda.gov
Container, Specimen, SterileFMH1Complaint file establishment, Specification developeraccessdata.fda.gov
Container, Specimen, Urine, Drugs Of Abuse, Over The CounterMPQ1Complaint file establishmentaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishment, Specification developeraccessdata.fda.gov
Contractor, SurgicalFZR1Specification developeraccessdata.fda.gov
CorkscrewHWI1Specification developeraccessdata.fda.gov
Cotton, RollEFN1Specification developeraccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Specification developeraccessdata.fda.gov
CountersinkHWW1Specification developeraccessdata.fda.gov
Cover, Barrier, ProtectiveMMP2Specification developeraccessdata.fda.gov
Cover, CastKIA1Specification developeraccessdata.fda.gov
Cover, LimbIPM1Specification developeraccessdata.fda.gov
Cover, Mattress (Medical Purposes)FMW1Specification developeraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Specification developeraccessdata.fda.gov
Coverslips, Microscope SlideKES1Complaint file establishmentaccessdata.fda.gov
Crimper, Wire, Ent, Non-SterileNNN1Specification developeraccessdata.fda.gov
CrutchIPR1Specification developeraccessdata.fda.gov
Cuff, Tracheal Tube, InflatableBSK2Specification developeraccessdata.fda.gov
Culture Media, Non-Propagating TransportJSM1Complaint file establishmentaccessdata.fda.gov
CuretteHTF1Specification developeraccessdata.fda.gov
Curette, EarJYG1Specification developeraccessdata.fda.gov
Curette, EndodonticEKT1Specification developeraccessdata.fda.gov
Curette, EthmoidKAO1Specification developeraccessdata.fda.gov
Curette, NasalKAP1Specification developeraccessdata.fda.gov
Curette, OphthalmicHNZ1Specification developeraccessdata.fda.gov
Curette, Surgical, DentalEMK1Specification developeraccessdata.fda.gov
Curette, Surgical, General UseFZS1Specification developeraccessdata.fda.gov
Curette, UterineHCY1Specification developeraccessdata.fda.gov
Cushion, FlotationKIC1Specification developeraccessdata.fda.gov
Cushion, WheelchairIMP1Specification developeraccessdata.fda.gov
Cutaneous Tissue Adhesive With MeshOMD2Complaint file establishmentaccessdata.fda.gov
Cutter, SurgicalFZT1Specification developeraccessdata.fda.gov
Cutter, WireHXZ1Specification developeraccessdata.fda.gov
CystotomeHNY1Specification developeraccessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)LDD2Complaint file establishmentaccessdata.fda.gov
Dental Hygiene KitNXZ1Specification developeraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Specification developeraccessdata.fda.gov
Depressor, OrbitalHNX1Specification developeraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Complaint file establishment, Specification developeraccessdata.fda.gov
DetergentJCB1Complaint file establishmentaccessdata.fda.gov
Device, Anti-Tip, WheelchairIMR1Specification developeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Specification developeraccessdata.fda.gov
Device, General Purpose, Microbiology, DiagnosticLIB1Complaint file establishmentaccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Specification developeraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Specification developeraccessdata.fda.gov
Device, Paste-On For Incontinence, Non-SterileNOA1Specification developeraccessdata.fda.gov
Device, Paste-On For Incontinence, SterileEXI1Complaint file establishment, Specification developeraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Specification developeraccessdata.fda.gov
Device, Specimen CollectionLIO1Complaint file establishmentaccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Specification developeraccessdata.fda.gov
Device, Vein StabilizationLBJ1Specification developeraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Complaint file establishmentaccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Complaint file establishmentaccessdata.fda.gov
Dilator, CatheterGCC1Specification developeraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Specification developeraccessdata.fda.gov
Dilator, LachrymalHNW1Specification developeraccessdata.fda.gov
Dilator, NasalLWF1Specification developeraccessdata.fda.gov
Dilator, TrachealKCG1Specification developeraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Specification developeraccessdata.fda.gov
Dish, Tissue CultureKIZ1Complaint file establishmentaccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Specification developeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Specification developeraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Specification developeraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Specification developeraccessdata.fda.gov
Dressing Change TrayOXQ1Specification developeraccessdata.fda.gov
Dressing, CompressionMHW1Specification developeraccessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicMGQUComplaint file establishment, Specification developeraccessdata.fda.gov
Dressing, Wound, DrugFROUComplaint file establishment, Specification developeraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Complaint file establishment, Specification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Complaint file establishment, Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Complaint file establishment, Specification developeraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)HBG2Specification developeraccessdata.fda.gov
Drink, Glucose ToleranceMRV2Complaint file establishmentaccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Complaint file establishmentaccessdata.fda.gov
Electrode, CutaneousGXY2Complaint file establishmentaccessdata.fda.gov
Electrode, ElectrocardiographDRX2Complaint file establishment, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Complaint file establishment, Specification developeraccessdata.fda.gov
Elevator, EntKAD1Specification developeraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Specification developeraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Specification developeraccessdata.fda.gov
Endoscopic Bite BlockMNK1Specification developeraccessdata.fda.gov
Endoscopic Irrigation/Suction SystemOCX2Specification developeraccessdata.fda.gov
Enteral Specific Transition ConnectorsPIO2Specification developeraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUComplaint file establishmentaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Complaint file establishmentaccessdata.fda.gov
Evacuator, Oral CavityEHZ1Specification developeraccessdata.fda.gov
Excavator, EarJYH1Specification developeraccessdata.fda.gov
Exerciser, Non-MeasuringION1Specification developeraccessdata.fda.gov
ExtractorHWB1Complaint file establishment, Specification developeraccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNSpecification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Complaint file establishment, Specification developeraccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
File, Bone, SurgicalEMI1Specification developeraccessdata.fda.gov
File, Surgical, General & Plastic SurgeryGEO1Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Complaint file establishmentaccessdata.fda.gov
Finger CotLZB1Specification developeraccessdata.fda.gov
First Aid Kit With DrugLRRNSpecification developeraccessdata.fda.gov
First Aid Kit Without DrugOHO1Specification developeraccessdata.fda.gov
Footrest, WheelchairIMM1Specification developeraccessdata.fda.gov
ForcepsHTD1Specification developeraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Specification developeraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Specification developeraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Specification developeraccessdata.fda.gov
Forceps, EntKAE1Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Specification developeraccessdata.fda.gov
Forceps, ObstetricalHDA2Specification developeraccessdata.fda.gov
Forceps, OphthalmicHNR1Specification developeraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Specification developeraccessdata.fda.gov
Forceps, Surgical, GynecologicalHCZ2Specification developeraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Specification developeraccessdata.fda.gov
ForkHXE1Specification developeraccessdata.fda.gov
Fork, TuningGWX1Specification developeraccessdata.fda.gov
Formalin, Neutral BufferedIFP1Complaint file establishmentaccessdata.fda.gov
Gag, MouthKBN1Specification developeraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Specification developeraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Specification developeraccessdata.fda.gov
Gauge, MeasuringJYJ1Specification developeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Specification developeraccessdata.fda.gov
Gauze/Sponge, InternalEFQUSpecification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Specification developeraccessdata.fda.gov
General Surgery TrayLRO2Specification developeraccessdata.fda.gov
Goniometer, NonpoweredKQW1Specification developeraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Specification developeraccessdata.fda.gov
Gown, ExaminationFME1Specification developeraccessdata.fda.gov
Gown, Isolation, SurgicalFYC2Specification developeraccessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionQPC2Specification developeraccessdata.fda.gov
Gown, SurgicalFYA2Specification developeraccessdata.fda.gov
Guard, InstrumentLXZ1Complaint file establishmentaccessdata.fda.gov
Guide, Drill, LigamentLXI1Complaint file establishment, Specification developeraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Specification developeraccessdata.fda.gov
Halter, Head, TractionHSS1Specification developeraccessdata.fda.gov
Hammer, SurgicalFZY1Specification developeraccessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE2Specification developeraccessdata.fda.gov
Helicobacter PyloriLYR1Complaint file establishmentaccessdata.fda.gov
Hematocrit, Tube, Rack, Sealer, HolderGHY2Specification developeraccessdata.fda.gov
HemostatHRQ1Specification developeraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUComplaint file establishmentaccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Specification developeraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Specification developeraccessdata.fda.gov
Hook, BoneKIK1Specification developeraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Specification developeraccessdata.fda.gov
Hook, Microsurgical EarJYL1Specification developeraccessdata.fda.gov
Hook, OphthalmicHNQ1Specification developeraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Specification developeraccessdata.fda.gov
Hook, TrachealKCH1Specification developeraccessdata.fda.gov
Humidifier Nebulizer KitOGG2Specification developeraccessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT2Specification developeraccessdata.fda.gov
ImpactorHWA1Specification developeraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Complaint file establishmentaccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Complaint file establishmentaccessdata.fda.gov
Infant Heel Warmer (Chemical Heat Pack)MPO1Complaint file establishmentaccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Specification developeraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Specification developeraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Specification developeraccessdata.fda.gov
Instrument, Cast Removal, Ac-PoweredLGH1Specification developeraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Specification developeraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Specification developeraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Specification developeraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Specification developeraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Specification developeraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUSpecification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Specification developeraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Specification developeraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Specification developeraccessdata.fda.gov
Irrigator, SinusKAR1Specification developeraccessdata.fda.gov
Jelly, Lubricating, For Transurethral Surgical InstrumentFHX2Specification developeraccessdata.fda.gov
Joint, Ankle, External BraceITW1Specification developeraccessdata.fda.gov
Joint, Knee, External BraceITQ1Specification developeraccessdata.fda.gov
Kit, Screening, UrineJXA1Complaint file establishmentaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Complaint file establishment, Specification developeraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Complaint file establishmentaccessdata.fda.gov
Knife, AmputationGDN1Specification developeraccessdata.fda.gov
Knife, EarJYO1Specification developeraccessdata.fda.gov
Knife, EntKTG1Specification developeraccessdata.fda.gov
Knife, LaryngealJZY1Specification developeraccessdata.fda.gov
Knife, NasalKAS1Specification developeraccessdata.fda.gov
Knife, OphthalmicHNN1Specification developeraccessdata.fda.gov
Knife, OrthopedicHTS1Specification developeraccessdata.fda.gov
Knife, SurgicalEMF1Specification developeraccessdata.fda.gov
Knife, TonsilKBQ1Specification developeraccessdata.fda.gov
Label Or Tag, SterileLYV1Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic Surgery, ReprocessedNLM2Specification developeraccessdata.fda.gov
Laparoscopic Bone Anchor Urethropexy Instrument KitNWN2Specification developeraccessdata.fda.gov
Laryngoscope, RigidCCW1Specification developeraccessdata.fda.gov
Latex Patient Examination GloveLYY1Complaint file establishment, Specification developeraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Specification developeraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Specification developeraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Specification developeraccessdata.fda.gov
Loop, WireJYQ1Specification developeraccessdata.fda.gov
Lubricant, PatientKMJ1Complaint file establishment, Specification developeraccessdata.fda.gov
MalletHXL1Specification developeraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Specification developeraccessdata.fda.gov
Marker, OcularHMR1Specification developeraccessdata.fda.gov
Marker, ScleraHMQ1Specification developeraccessdata.fda.gov
Marker, SkinFZZ1Specification developeraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Specification developeraccessdata.fda.gov
Mask, OxygenBYG1Specification developeraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Specification developeraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Specification developeraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Specification developeraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Specification developeraccessdata.fda.gov
Media, Coupling, UltrasoundMUI2Complaint file establishmentaccessdata.fda.gov
Media, ElectroconductiveGYB2Specification developeraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Complaint file establishment, Specification developeraccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Specification developeraccessdata.fda.gov
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy DrugsQSO2Specification developeraccessdata.fda.gov
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of TendonOWX2Complaint file establishmentaccessdata.fda.gov
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of LigamentQUW2Complaint file establishmentaccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Complaint file establishmentaccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Complaint file establishmentaccessdata.fda.gov
Micro PipetteJRC1Complaint file establishmentaccessdata.fda.gov
Mirror, MouthEAX1Specification developeraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Specification developeraccessdata.fda.gov
Mobilizer, EntKAJ1Specification developeraccessdata.fda.gov
Monitor, Bed PatientKMI1Specification developeraccessdata.fda.gov
Mouthpiece, BreathingBYP1Specification developeraccessdata.fda.gov
Multi-Analyte Respiratory Virus Antigen Detection TestSCA2Complaint file establishmentaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Complaint file establishment, Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Specification developeraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Complaint file establishment, Specification developeraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Specification developeraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Specification developeraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Specification developeraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Specification developeraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Specification developeraccessdata.fda.gov
Neurosurgical PaddieHBA2Specification developeraccessdata.fda.gov
Nipper, MalleusJYR1Specification developeraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Complaint file establishmentaccessdata.fda.gov
Non-Coring (Huber) NeedlePTI2Complaint file establishmentaccessdata.fda.gov
Non-Surgical GownOEA1Specification developeraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic TrayOJH1Specification developeraccessdata.fda.gov
Orthosis, AbdominalKTD1Specification developeraccessdata.fda.gov
Orthosis, CervicalIQK1Specification developeraccessdata.fda.gov
Orthosis, Cervical-Thoracic, RigidIQF1Specification developeraccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Specification developeraccessdata.fda.gov
Orthosis, Foot DropOHI1Specification developeraccessdata.fda.gov
Orthosis, Limb BraceIQI1Specification developeraccessdata.fda.gov
Orthosis, LumbarIQE1Specification developeraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Specification developeraccessdata.fda.gov
OsteotomeHWM1Specification developeraccessdata.fda.gov
Osteotome, ManualGFI1Specification developeraccessdata.fda.gov
OximeterDQA2Complaint file establishment, Specification developeraccessdata.fda.gov
Oximeter, ReprocessedNLF2Specification developeraccessdata.fda.gov

218 more device types in the FDA listing

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 357.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 25, 2026K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)BZESubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
February 25, 2026K251687Konig Bell Circumcision ClampHFXSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
November 20, 2025K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXCSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
August 20, 2025K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestSCASubstantially EquivalentWondfo USA Co, Ltd.accessdata.fda.gov
July 2, 2025K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallBTTSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
May 13, 2025K251138Promisemed Safety Huber NeedlesPTISubstantially EquivalentPromisemed Hangzhou Meditech Co., Ltd.accessdata.fda.gov
April 11, 2025K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDRSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
February 26, 2025K242844Medline Level 4 Surgical Gown with Breathable SleevesFYASubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
February 21, 2025K243431Medicom Sterilization Pouch and ReelFRGSubstantially EquivalentMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.accessdata.fda.gov
December 19, 2024K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))GEISubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
December 19, 2024K241778Hudson RCI Comfort Flo® CubCannula™BTTSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
October 16, 2024K242839Safe Secure Sterilization Pouches and RollsFRGSubstantially EquivalentShenzhen Safesecure Medical Infection Control Tech Co. , Ltd.accessdata.fda.gov
October 7, 2024DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestSCAUnknownHealgenaccessdata.fda.gov
September 27, 2024K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTTSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
September 17, 2024K234132Medline Reusable Sterilization WrappersFRGSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
September 13, 2024K233399Microdacyn Wound Care SolutionFROSubstantially EquivalentSonoma Pharmaceuticals, Inc.accessdata.fda.gov
August 22, 2024K242126I.V. Administration SetFPASubstantially EquivalentBq Plus Medical Co., Ltd.accessdata.fda.gov
August 2, 2024K241359Medline UNITE® MIS Foot Recon Screw SystemHWCSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
June 4, 2024K234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineBZESubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
May 20, 2024K223399AViTA Pulse OximeterDQASubstantially EquivalentAvita Corporationaccessdata.fda.gov
March 27, 2024K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingFROSubstantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.accessdata.fda.gov
March 26, 2024K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)FROSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
March 5, 2024K233526Medline Open-back Level 3 Protective GownQPCSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
January 18, 2024K234031Medline UNITE Ancillary Foot Recon Plating SystemHRSSubstantially EquivalentMedline Industires, LPaccessdata.fda.gov
January 8, 2024K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1GEISubstantially EquivalentBaisheng Medical Co., Ltd.accessdata.fda.gov
January 4, 2024K231058Hudson RCI® AddiPak® Unit Dose VialCAFSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
December 15, 2023K232957Sterile and Non-Sterile Ultrasound GelsMUISubstantially EquivalentJianerkang Medical Co., Ltd.accessdata.fda.gov
December 1, 2023K231211Medline ComfortTemp Patient Warming SystemDWJSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
October 31, 2023K230602Hudson RCI® TurboMist™ Nebulizer SystemCAFSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
October 26, 2023K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)BTTSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 19, 2023K232905Medline UNITE® REFLEX® Nitinol Staple KitJDRSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
October 18, 2023K231907Medline Safety Insulin and TB SyringesMEGSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
October 3, 2023K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IORSubstantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.accessdata.fda.gov
September 21, 2023K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaFOZSubstantially EquivalentPoly Medicure Limitedaccessdata.fda.gov
September 19, 2023K230966angiOCCLUDE Ligating ClipsFZPSubstantially EquivalentA2 Medical Systems, LLCaccessdata.fda.gov
August 9, 2023K231885Medline UNITE® REFLEX® Nitinol Staple SystemJDRSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
June 27, 2023K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)CAFSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
June 23, 2023K220955Hudson RCI Variable concentration Large Volume Nebulizer (1770)CAFSubstantially EquivalentMedline Industires, Inc.accessdata.fda.gov
May 5, 2023K230616Polyguard and Polyshield Safety IV CathetersFOZSubstantially EquivalentPoly Medicure Limitedaccessdata.fda.gov
May 3, 2023K230123Apollo Knotless Suture AnchorMBISubstantially EquivalentMaruho Medicalaccessdata.fda.gov
April 19, 2023K220288NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free ConnectorFPASubstantially EquivalentNp Medical, Inc.accessdata.fda.gov
March 24, 2023K223236Medline Surgical Face Mask and Medline Procedural Face MaskFXXSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
January 25, 2023K222665Medline UNITE® Ankle Fusion Plating SystemHRSSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
January 11, 2023K221278Transducer Probe CoverITXSubstantially EquivalentHony Medical Co., Ltd.accessdata.fda.gov
December 27, 2022K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceQUWSubstantially EquivalentXiros, Ltd.accessdata.fda.gov
December 21, 2022K221720Extra Silver Gelling Fiber DressingFROSubstantially EquivalentWinner Medical Co., Ltd.accessdata.fda.gov
December 9, 2022K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeFMFSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
November 18, 2022K212911Konig Mogen ClampHFXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
November 17, 2022K220739Disposable Urine Collection TubeJSMSubstantially EquivalentZhejiang Gongdong Medical Technology Co., Ltd.accessdata.fda.gov
October 25, 2022K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWFSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 6, 2022K220365Gemini Sterilization WrapFRGSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
September 27, 2022K221360Medline UNITE® Medial Malleolus Peg Plate SystemHRSSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
July 21, 2022K220184Pump Alignment SyringeFMFSubstantially EquivalentJiangsu Caina Medical Co.,Ltdaccessdata.fda.gov
May 24, 2022K213481Medline General Surgery TrayLROSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
May 23, 2022K211878LiquiBand XLOMDSubstantially EquivalentAdvanced Medical Solutions Limitedaccessdata.fda.gov
May 19, 2022K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)FMKSubstantially EquivalentTianjin Huahong Technology Co., Ltd.accessdata.fda.gov
May 18, 2022K220333Medline Orbis LVL 3 Surgical GownFYASubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
May 6, 2022K214108Medline Orbis Chemo Surgical GownFYASubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
March 22, 2022K220511Medline UNITE IM Fibula ImplantHWCSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
March 16, 2022K212623Healgen Strep A Rapid Test Strip (Throat Swab)GTYSubstantially EquivalentHealgen Scientific,, LLCaccessdata.fda.gov
March 2, 2022K220006angioLOCK Polymer Ligating ClipFZPSubstantially EquivalentA2 Medical Systems, LLCaccessdata.fda.gov
March 2, 2022K213567Medline UNITE Calcaneal Fracture Plating SystemHRSSubstantially EquivalentMedline Industries, LPaccessdata.fda.gov
January 14, 2022K212093Medline Universal Grounding PadGEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
January 3, 2022K213068Medline Smoke Evacuation ShroudFYDSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
December 10, 2021K211612Medline UNITE REFLEX Dynamic DiscsHTNSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
September 20, 2021K211931Medline Digital Thermometer Non-Lubricated Probe SheathFLLSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 26, 2021K202802TT Electric Breast Pump, TT Double Electric Breast PumpHGXSubstantially EquivalentWuxi Xinzhongrui Baby Supplies Co., Ltd.accessdata.fda.gov
August 2, 2021K203538SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)KGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
July 22, 2021K211944Medline UNITE® Digital Fusion Screw SystemHWCSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
July 17, 2021K211177Powder Free Vinyl Patient Examination GlovesLYZSubstantially EquivalentShijiazhuang Hongjun Plastic Manufacture Co., Ltd.accessdata.fda.gov
May 4, 2021K203135Medline Vacu-line Suction AspiratorBTASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 22, 2021K210482Medline UNITE REFLEX Nitinol Staple SystemJDRSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 2, 2021K202447Medline Orbis Surgical GownFYASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 12, 2021K210526Medline Cautery Tip CleanerGEISubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
February 1, 2021K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesKGOSubstantially EquivalentGuilin Hbm Health Protections, Inc.accessdata.fda.gov
December 19, 2020K202668Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable ProteinKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
November 23, 2020K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)FLLSubstantially EquivalentDongguan E-Test Technology Co., Ltd.accessdata.fda.gov
November 18, 2020K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable ProteinKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 26, 2020K202179Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)LYZSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 26, 2020K200150Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)LZASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
October 16, 2020K201129Medline Smoke Evacuation PencilGEISubstantially EquivalentMedline Industires, Inc.accessdata.fda.gov
September 25, 2020K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
September 9, 2020K201829SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)KGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
August 19, 2020K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQSubstantially EquivalentSurgical Instrument Service and Savings Inc.(Dba Medline Renaccessdata.fda.gov
August 4, 2020K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended CuffLZASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
July 22, 2020K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorNLFSubstantially EquivalentSurgical Instrument and Savings Inc (Dba Medline Renewal)accessdata.fda.gov
July 13, 2020K200960Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)LZASubstantially EquivalentMedline Industires, Inc.accessdata.fda.gov
July 12, 2020K193627Automatic Upper Arm Blood Pressure MonitorDXNSubstantially EquivalentDongguan E-Test Technology Co., Ltd.accessdata.fda.gov
June 18, 2020K193513SIGNAFUSE Bioactive Bone GraftMQVSubstantially EquivalentBioventusaccessdata.fda.gov
June 17, 2020K201319Medline UNITE Jones Fracture Screw SystemHWCSubstantially EquivalentMedline Industires, Inc.accessdata.fda.gov
April 6, 2020K193217SensiCare PI and SensiCare PI Micro Surgical GlovesKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
April 1, 2020K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for UseKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 26, 2020K193108Bonecam Suture AnchorMBISubstantially EquivalentValeris Medical, Inc.accessdata.fda.gov
March 17, 2020K191753Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)LZASubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
March 11, 2020K192810Apollo Suture Anchor SystemMBISubstantially EquivalentValeris Medicalaccessdata.fda.gov
March 9, 2020K183570LiquiBand PlusMPNSubstantially EquivalentAdvanced Medical Solutions Limitedaccessdata.fda.gov
March 6, 2020K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe VKGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
February 28, 2020K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)KGOSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
January 24, 2020K192641Gemini Titan Sterilization WrapFRGSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
January 21, 2020K192985Medline Glide-On 3G Vinyl Examination GlovesLYZSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 249.

InitiatedEventClassStatusProductReasonSource
September 11, 202699983Class IIOngoingMedline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395ADiscrepancy in the shelf-life of a componentaccessdata.fda.gov
September 9, 202699960Class IIOngoingMEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.accessdata.fda.gov
September 2, 202699886Class IIOngoingMedline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925DMedical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.accessdata.fda.gov
August 31, 202699888Class IIOngoingConvenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720AKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.accessdata.fda.gov
August 14, 202699827Class IOngoingMedline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED MDR540094 PENDANT, Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.accessdata.fda.gov
August 14, 202699807Class IIOngoingRollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWSThe front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences caccessdata.fda.gov
August 11, 202699669Class IOngoingMedline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, accessdata.fda.gov
August 10, 202699739Class IIOngoingMedline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, CaThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.accessdata.fda.gov
August 10, 202699729Class IIOngoingMedline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.accessdata.fda.gov
July 31, 202699667Class IIOngoingConvenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.accessdata.fda.gov
July 23, 202699583Class IIOngoingMedline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NThe kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile devicaccessdata.fda.gov
July 20, 202699561Class IIOngoingMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476ADownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.accessdata.fda.gov
July 13, 202699403Class IIOngoingMedline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuitNeonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertaccessdata.fda.gov
July 10, 202699507Class IIOngoingMedline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.Kits contain a potentially contaminated component which were recalled by the manufactureraccessdata.fda.gov
July 10, 202699506Class IIOngoingMedline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330Component labeling discrepancyaccessdata.fda.gov
July 8, 202699489Class IIOngoingMedline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.accessdata.fda.gov
June 30, 202699432Class IIOngoingMedline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400ANMedline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.accessdata.fda.gov
June 12, 202699334Class IIOngoingMedline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199AThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no inaccessdata.fda.gov
June 11, 202699329Class IIOngoingMedline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.accessdata.fda.gov
June 10, 202699318Class IIOngoingMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.accessdata.fda.gov
June 8, 202699301Class IIOngoingMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116IAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.accessdata.fda.gov
June 8, 202699297Class IOngoingMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556NThe procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.accessdata.fda.gov
June 5, 202699290Class IOngoingMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640GMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injecaccessdata.fda.gov
May 28, 202699209Class IIOngoingMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530BKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.accessdata.fda.gov
May 28, 202699196Class IIOngoingMedline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125AConvenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.accessdata.fda.gov
May 21, 202699162Class IIOngoingMedline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010BThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.accessdata.fda.gov
May 15, 202699122Class IOngoingReprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it maccessdata.fda.gov
May 6, 202699043Class IOngoingMedline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UPThe Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.accessdata.fda.gov
May 4, 202698994Class IIOngoingMEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.accessdata.fda.gov
April 27, 202698951Class IIOngoingMedline EBSI Kit EBSI1534Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.accessdata.fda.gov
April 10, 202698866Class IIOngoingMedline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627PSpecific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.accessdata.fda.gov
April 10, 202698837Class IOngoingMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.accessdata.fda.gov
March 24, 202698735Class IOngoingNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.Medline has identified the presence of particulate within the fluid path of the Manifolds.accessdata.fda.gov
March 19, 202698664Class IIOngoingMedline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.accessdata.fda.gov
March 16, 202698692Class IIOngoingCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.accessdata.fda.gov
March 16, 202698626Class IIOngoingCENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050FOn lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.accessdata.fda.gov
February 27, 202699062Class IIOngoingConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.accessdata.fda.gov
February 27, 202698601Class IIOngoingMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ2Unapproved design changes to the products outside of the 510(k) clearance.accessdata.fda.gov
February 27, 202698598Class IOngoingNAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRIMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.accessdata.fda.gov
February 25, 202698599Class IIOngoingMedline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIREThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.accessdata.fda.gov
February 18, 202698529Class IIOngoingSterile Radiology Procedure Kits, Model Number DYNDH1491BThere is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.accessdata.fda.gov
February 16, 202698530Class IIOngoingAirway Exam Kit, DYKE1796Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Otheraccessdata.fda.gov
February 13, 202698524Class IIOngoingENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GCConnectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infaccessdata.fda.gov
February 10, 202698484Class IIOngoingPuracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.accessdata.fda.gov
January 30, 202698437Class IIOngoingMedline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.accessdata.fda.gov
January 28, 202698430Class IIOngoingMedline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,LFabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.accessdata.fda.gov
January 8, 202698333Class IIOngoingMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leaaccessdata.fda.gov
January 7, 202698642Class IIOngoingMedline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567AMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.accessdata.fda.gov
January 7, 202698329Class IIOngoingMedline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567AMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.accessdata.fda.gov
January 5, 202698319Class IIOngoingMedline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.accessdata.fda.gov
December 31, 202598299Class IIOngoingMedline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEUnder circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.accessdata.fda.gov
December 24, 202598285Class IIOngoingMedline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kitA smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiaccessdata.fda.gov
December 24, 202598284Class IIOngoingMedline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387BMedline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.accessdata.fda.gov
December 22, 202598277Class IOngoingMedline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJThese lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025accessdata.fda.gov
December 16, 202598197Class IIOngoingMedline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.accessdata.fda.gov
December 12, 202598226Class IIOngoingMedline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.accessdata.fda.gov
November 26, 202598185Class IOngoingMEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, poaccessdata.fda.gov
November 26, 202598154Class IIOngoingMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014BMedline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.accessdata.fda.gov
November 21, 202598125Class IIOngoingMedline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7'Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.accessdata.fda.gov
November 13, 202598066Class IIOngoingSCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.accessdata.fda.gov
November 11, 202598056Class IIOngoingDEXLOCK Achilles Repair Implant Kits, MAKT4520There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.accessdata.fda.gov
October 27, 202597978Class IIOngoingCURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930FMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.accessdata.fda.gov
October 27, 202597968Class IIOngoingMEDLINE PERFUSION SYRINGE, REF: DYNJ39223CMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does notaccessdata.fda.gov
October 10, 202597882Class IOngoingAnesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.accessdata.fda.gov
October 3, 202597815Class IIOngoingMEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.accessdata.fda.gov
October 1, 202597822Class IIOngoingMedline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation DeviceMedline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.accessdata.fda.gov
September 30, 202597846Class IIOngoingMEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418MMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the accessdata.fda.gov
September 11, 202597675Class IIOngoingExcelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringesMedline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.accessdata.fda.gov
September 10, 202597650Class IIOngoingMedline Adult Anesthesia Set, REF DYNJ39985GSpecific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.accessdata.fda.gov
August 21, 202597555Class IOngoingMedline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366QThe kits contain certain lots of cannula products where the catheter may not retain its shape.accessdata.fda.gov
August 8, 202597495Class IOngoingSterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038BConvenience kits labeled as sterile have not gone through the sterilization process.accessdata.fda.gov
July 31, 202597496Class IOngoingReprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 40193Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heaaccessdata.fda.gov
July 25, 202597411Class IOngoingMedline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.accessdata.fda.gov
July 23, 202597388Class IIOngoingMedline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR wereKits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).accessdata.fda.gov
July 14, 202597357Class IOngoingMedline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH,Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.accessdata.fda.gov
July 8, 202597371Class IIOngoingThe Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent uponAffected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in touraccessdata.fda.gov
June 16, 202597169Class IIOngoingSwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.accessdata.fda.gov
June 12, 202597154Class IIOngoingMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.accessdata.fda.gov
May 23, 202597027Class IIOngoingMedline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.accessdata.fda.gov
May 15, 202596959Class IIOngoingMedline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.accessdata.fda.gov
April 22, 202596821Class IOngoingMedline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIAffected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.accessdata.fda.gov
April 9, 202596732Class IIOngoingCenturion Sterile Weitlaner Retractor, Reorder: 67315Three is the potential for the retractors to puncture through the sterile packaging.accessdata.fda.gov
March 24, 202596662Class IIOngoingMeridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.accessdata.fda.gov
March 19, 202596630Class IIOngoingMedline Sterile Water, USP, 100mL, REF RDI30295It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.accessdata.fda.gov
March 5, 202596541Class IIOngoingMEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720RMedline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.accessdata.fda.gov
March 3, 202596510Class IIOngoingMedline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.accessdata.fda.gov
February 24, 202596472Class IOngoingMedline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC0Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.accessdata.fda.gov
February 21, 202596443Class IOngoingMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1Medline medical procedure kits, containing Medtronic Aortic Root Cannulaaccessdata.fda.gov
February 19, 202596425Class IIOngoingWayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPThere is a potential for the sterility of the device to be compromised.accessdata.fda.gov
February 13, 202596401Class IIOngoingProxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,STPotential breach in pouch packaging which could lead to loss of sterility.accessdata.fda.gov
February 12, 202596367Class IIOngoingnamic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kitThe female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.accessdata.fda.gov
February 11, 202596374Class IIOngoingMedline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.accessdata.fda.gov
February 11, 202596373Class IIOngoingMedline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ5Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.accessdata.fda.gov
February 11, 202596372Class IIOngoingMedline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.accessdata.fda.gov
February 6, 202596368Class IIOngoingMedline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991RDevices may have higher than expected amounts of bacterial endotoxin.accessdata.fda.gov
January 9, 202596188Class IIOngoingMedline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262AKits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.accessdata.fda.gov
January 3, 202596163Class IIOngoingMedline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kitMedline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.accessdata.fda.gov
December 31, 202496093Class IOngoingMedline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.accessdata.fda.gov
December 23, 202496066Class IIOngoingCENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.accessdata.fda.gov
December 16, 202495988Class IOngoingMedline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item NumFluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.accessdata.fda.gov

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Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.