Data / Medical devices / United States / Karl Storz Endoscopy-America, Inc.

Karl Storz Endoscopy-America, Inc.: FDA-registered device maker in Auburn, MA, United States, 436 510(k) clearances and 1 PMA approval

Name: Karl Storz Endoscopy-America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Karl Storz Endoscopy-America, Inc. is registered with the FDA (registration 2020550) in Auburn, MA, United States. It lists 207 device types. The FDA files 436 510(k) clearances and 1 PMA approval under its listings, the newest dated September 25, 2026. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 2020550
Address: 28 Millbury Street, Auburn, MA, United States, 01501
Owner or operator: KARL STORZ SE & CO KG (8010119)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: June 20, 1978
Registered through: 2027
Brand names listed: 11274AB Flex Pediatric BRONCHOSCOPE, 11274AC Flex. CHOLEDOCHOSCOPE, 26025UC HAMOU Elctrnc HYSTEROFLATOR, 2800C Shouldr/Ankle/Elbw/Hip/TMJ/SM, 300W Light Source, Non-flash, 3D Endoscope, 3D Video System, 495N Series Fibr Optic Light Cables and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Blood Circuit, Hemodialysis	KOC	2	Repackager or relabeler	accessdata.fda.gov
Accessories, Catheter, G-U	KNY	2	Repackager or relabeler	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Amnioscope, Transabdominal (Fetoscope) (And Accessories)	HFA	f	Repackager or relabeler	accessdata.fda.gov
Angioscope	LYK	2	Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Attachment, Eyepiece, For Insertion Of Prescription Lens	FDZ	1	Repackager or relabeler	accessdata.fda.gov
Attachment, Teaching, For Endoscope	FEA	1	Repackager or relabeler	accessdata.fda.gov
Basin For Endoscope Reprocessing	PHT	1	Repackager or relabeler	accessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Repackager or relabeler	accessdata.fda.gov
Blower, Powder, Ent	KCL	1	Repackager or relabeler	accessdata.fda.gov
Bottle, Collection And Trap, Breathing System (Uncalibrated)	CBC	2	Repackager or relabeler	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Repackager or relabeler	accessdata.fda.gov
Bougie, Esophageal, Ent	KCD	1	Repackager or relabeler	accessdata.fda.gov
Bougie, Urological	FAX	1	Repackager or relabeler	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Brush, Dermabrasion, Manual	GED	1	Repackager or relabeler	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Repackager or relabeler	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Repackager or relabeler	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Repackager or relabeler	accessdata.fda.gov
Camera, Cine, Endoscopic, With Audio	FTS	1	Repackager or relabeler	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Repackager or relabeler	accessdata.fda.gov
Camera, Still, Endoscopic	FXM	1	Repackager or relabeler	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Repackager or relabeler	accessdata.fda.gov
Camera, Television, Surgical, With Audio	FWC	1	Repackager or relabeler	accessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-Disposable	FBM	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Repackager or relabeler	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Repackager or relabeler	accessdata.fda.gov
Chair And Table, Medical	KMN	1	Repackager or relabeler	accessdata.fda.gov
Choledochoscope And Accessories, Flexible/Rigid	FBN	2	Repackager or relabeler	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Line	FKK	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Vascular	DXC	2	Repackager or relabeler	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	HIN	2	Repackager or relabeler	accessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	KNF	2	Repackager or relabeler	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Repackager or relabeler	accessdata.fda.gov
Confocal Optical Imaging	OWN	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Repackager or relabeler	accessdata.fda.gov
Culdoscope (And Accessories)	HEW	2	Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Curette, Uterine	HCY	1	Repackager or relabeler	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Cystourethroscope	FBO	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Catheter	GCC	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Catheter, Ureteral	EZN	2	Repackager or relabeler	accessdata.fda.gov
Dilator, Urethral	KOE	2	Repackager or relabeler	accessdata.fda.gov
Dilator, Urethral, Mechanical	FAH	2	Repackager or relabeler	accessdata.fda.gov
Dilator, Vaginal	HDX	2	Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Flexible	FGO	2	Repackager or relabeler	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Repackager or relabeler	accessdata.fda.gov
Drape, Microscope, Ophthalmic	HMW	2	Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Repackager or relabeler	accessdata.fda.gov
Duodenoscope And Accessories, Flexible/Rigid	FDT	2	Repackager or relabeler	accessdata.fda.gov
Ear, Nose, And Throat Stereotaxic Instrument	PGW	2	Repackager or relabeler	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Electrosurgical	JOS	2	Repackager or relabeler	accessdata.fda.gov
Electrode, Electrosurgical, Active, Urological	FAS	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Elevator	HTE	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Ent	KAD	1	Repackager or relabeler	accessdata.fda.gov
Endoscope Holder	OCV	2	Repackager or relabeler	accessdata.fda.gov
Endoscope, Fetal Blood Sampling (And Accessories)	HGK	2	Repackager or relabeler	accessdata.fda.gov
Endoscope, Neurological	GWG	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscope, Rigid	GCM	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Repackager or relabeler	accessdata.fda.gov
Endoscopic Central Control Unit	ODA	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Contamination Prevention Sheath	ODB	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered	OCZ	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Esophagoscope (Flexible Or Rigid)	EOX	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Evacuator, Bladder, Manually Operated	FFD	1	Repackager or relabeler	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Repackager or relabeler	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Ent	KAE	1	Repackager or relabeler	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Tube Introduction	BWB	1	Repackager or relabeler	accessdata.fda.gov
Fork, Tuning	GWX	1	Repackager or relabeler	accessdata.fda.gov
Gag, Mouth	KBN	1	Repackager or relabeler	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Repackager or relabeler	accessdata.fda.gov
Headlamp, Operating, Battery-Operated	HPP	1	Repackager or relabeler	accessdata.fda.gov
Holder, Ear Speculum	JYK	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Repackager or relabeler	accessdata.fda.gov
Hook, Microsurgical Ear	JYL	1	Repackager or relabeler	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Repackager or relabeler	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Repackager or relabeler	accessdata.fda.gov
Image, Illumination, Fiberoptic, For Endoscope	FFS	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, General Obstetric-Gynecologic	KOH	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Special Lens, For Endoscope	FEI	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Repackager or relabeler	accessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For Endoscope	FCX	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Insufflator, Endoscopic Vessel Harvesting	OSV	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Irrigator, Powered Nasal	KMA	1	Repackager or relabeler	accessdata.fda.gov
Kit, Nephroscope	FGA	2	Repackager or relabeler	accessdata.fda.gov
Knife, Ent	KTG	1	Repackager or relabeler	accessdata.fda.gov
Knife, Nasal	KAS	1	Repackager or relabeler	accessdata.fda.gov
Knife, Surgical	EMF	1	Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Endoscope	GCI	2	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Laryngostroboscope	EQL	1	Repackager or relabeler	accessdata.fda.gov
Led Light Source	NTN	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Light Source System, Diagnostic Endoscopic	OAY	3	Repackager or relabeler	accessdata.fda.gov
Light Source, Endoscope, Xenon Arc	GCT	2	Repackager or relabeler	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Repackager or relabeler	accessdata.fda.gov
Light Source, Photographic, Fiberoptic	FCR	2	Repackager or relabeler	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Repackager or relabeler	accessdata.fda.gov
Light, Headband, Surgical	FSR	2	Repackager or relabeler	accessdata.fda.gov
Light, Surgical Headlight	EBA	1	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Carrier	FSZ	2	Repackager or relabeler	accessdata.fda.gov
Lithotriptor, Biliary Mechanical	LQC	2	Repackager or relabeler	accessdata.fda.gov
Lithotriptor, Electro-Hydraulic	FFK	2	Repackager or relabeler	accessdata.fda.gov
Lithotriptor, Extracorporeal Shock-Wave, Urological	LNS	2	Repackager or relabeler	accessdata.fda.gov
Lithotriptor, Ultrasonic	FEO	2	Repackager or relabeler	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Repackager or relabeler	accessdata.fda.gov
Mediastinoscope, Surgical	EWY	2	Repackager or relabeler	accessdata.fda.gov
Microscope, Surgical	EPT	1	Repackager or relabeler	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Repackager or relabeler	accessdata.fda.gov
Mirror, Ent	KAI	1	Repackager or relabeler	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Repackager or relabeler	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Reusable	GDM	1	Repackager or relabeler	accessdata.fda.gov
Obturator, For Endoscope	FEC	2	Repackager or relabeler	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
Otoscope	ERA	1	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Proctoscope	GCF	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Partial Ossicular Replacement	ETB	2	Repackager or relabeler	accessdata.fda.gov
Pump, Air, Non-Manual, For Endoscope	FEQ	2	Repackager or relabeler	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Nasal	KAY	1	Repackager or relabeler	accessdata.fda.gov
Replacement, Ossicular Prosthesis, Total	ETA	2	Repackager or relabeler	accessdata.fda.gov
Resectoscope	FJL	2	Repackager or relabeler	accessdata.fda.gov
Resectoscope, Working Element	FDC	2	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Ent	KAL	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Repackager or relabeler	accessdata.fda.gov
Saw, Surgical, Ent (Electric Or Pneumatic)	EWQ	1	Repackager or relabeler	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Repackager or relabeler	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Repackager or relabeler	accessdata.fda.gov
Snare, Flexible	FDI	2	Repackager or relabeler	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Ent	EPY	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Illuminated	FXF	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Metal, Fiberoptic	HDG	1	Repackager or relabeler	accessdata.fda.gov
Splint, Nasal	EPP	1	Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Repackager or relabeler	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Repackager or relabeler	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Repackager or relabeler	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Repackager or relabeler	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Repackager or relabeler	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	PYO	1	Repackager or relabeler	accessdata.fda.gov
Telescope, Laryngeal-Bronchial	ENZ	2	Repackager or relabeler	accessdata.fda.gov
Transilluminator, Fiber Optic	MQW	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Trocar, Gastro-Urology	FBQ	2	Repackager or relabeler	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Repackager or relabeler	accessdata.fda.gov
Tube, Smoke Removal, Endoscopic	FCZ	1	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Repackager or relabeler	accessdata.fda.gov
Tubing And Tubing/Filter Fits	NVT	1	Repackager or relabeler	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Repackager or relabeler	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	Repackager or relabeler	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Repackager or relabeler	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Urethroscope	FGC	2	Repackager or relabeler	accessdata.fda.gov
Urethrotome	EZO	2	Repackager or relabeler	accessdata.fda.gov
Vaginoscope And Accessories	MOK	2	Repackager or relabeler	accessdata.fda.gov
Withdrawal/Infusion Pump	DQI	2	Repackager or relabeler	accessdata.fda.gov
Yoke Assembly, Medical Gas	CAM	1	Repackager or relabeler	accessdata.fda.gov

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 436.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 25, 2026	K254252	UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)	HIH	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 24, 2026	K254303	KARL STORZ SUPRALOOP	KNF	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 18, 2026	K261102	UNIDRIVE Select System	HIH	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 1, 2026	K260884	UNIDRIVE Select System	GCJ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
August 26, 2026	K254103	HOPKINS Telescopes for Arthroscopy	HRX	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
June 3, 2026	K252800	KARL STORZ Endoscopic Accessories for Urology	OCZ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
May 11, 2026	K254228	KARL STORZ Trocars with Valve Seals	GCJ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
March 2, 2026	K260003	KARL STORZ Mediastinoscopes and Instruments	EWY	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
February 26, 2026	K254242	KARL STORZ ICG Imaging System with RUBINA® Lens	OWN	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
February 12, 2026	K253972	IMAGE1 (TC400US); X-to-4U Adapter (TC040)	OWN	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
December 5, 2025	K251731	KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)	EOQ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
November 22, 2025	K250927	KARL STORZ Cholangiography Set	GCJ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
November 18, 2025	K253411	Miniature Telescope for Urology (27033AA)	FGB	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 22, 2025	K250388	ENDOFLATOR +	HIF	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
August 13, 2025	K243653	KARL STORZ HOPKINS Telescopes for Urology	FAJ	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
June 6, 2025	K243550	KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)	FGB	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
May 2, 2025	K244001	KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)	FBO	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
November 27, 2024	K243409	KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)	FBO	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
October 22, 2024	K240506	KARL STORZ Holders	OCV	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
August 1, 2024	K241945	KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)	FGB	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
July 25, 2024	K233372	KARL STORZ Fiber Telescopes for Urology	FGB	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
June 10, 2024	K232911	KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)	FGB	Substantially Equivalent	Karl Storz Endovision, Inc.	accessdata.fda.gov
May 7, 2024	K232486	KARL STORZ Monopolar Resectoscopes with HF Cable	FJL	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
May 1, 2024	K232370	Percutaneous Nephroscope System	FGA	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
October 3, 2023	K232406	KARL STORZ OR1 SCB CONTROL (WU300)	ODA	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 14, 2023	K223885	HOPKINS Telescopes	HIH	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
September 8, 2023	K230535	KARL STORZ Urological Laser Accessories	GEX	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
June 23, 2023	K230359	KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-	GCJ	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
April 27, 2023	K223520	UNIDRIVE SIII System	HIH	Substantially Equivalent	Karl Storz-Endoscopy-America, Inc.	accessdata.fda.gov
March 30, 2023	K223923	HOPKINS Telescopes	GCJ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
March 17, 2023	K221893	KARL STORZ Bipolar Resectoscopes with HF Cable	FJL	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
December 20, 2022	K221004	HOPKINS Telescopes	GCJ	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
November 10, 2022	K222504	H1	GCJ	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
November 15, 2021	K212695	KARL STORZ ICG Imaging System	OWN	Substantially Equivalent	Karl Storz Endoscopy America	accessdata.fda.gov
September 3, 2021	K212476	KARL STORZ Flexible HD Cysto-Urethroscope System	FAJ	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
July 6, 2021	K203198	KARL STORZ Metal Sterilization Trays	KCT	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
May 7, 2021	K203572	Karl Storz Radel Sterilization Trays	KCT	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
February 25, 2021	K201945	KARL STORZ UDEL Sterilization Trays	KCT	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
December 17, 2020	K202925	KARL STORZ ICG Imaging System	OWN	Substantially Equivalent	Karl Storz Endoscopy_America, Inc.	accessdata.fda.gov
November 20, 2020	K201526	TIPCAM1 Rubina Video Endoscope System	GCJ	Substantially Equivalent	Karl Storz Endoscopy America	accessdata.fda.gov
October 22, 2020	K200318	UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece	ERL	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
September 1, 2020	K201135	Image1 S CCU, Image1 S 4U Camera Head	FET	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 17, 2020	K201399	HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head	OWN	Substantially Equivalent	Karl Storz-Endoscopy-America, Inc.	accessdata.fda.gov
August 11, 2020	K200740	HD Video Rhino Laryngoscope	EOB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
June 23, 2020	K201096	CO2mbiLED	FCX	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
January 24, 2020	K192523	CMOS Video Esophagoscope SSU	EOX	Substantially Equivalent	Karl Storz SE & CO. KG	accessdata.fda.gov
September 18, 2019	K191357	Flexible HD Cysto-Urethroscope System	FAJ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
April 23, 2019	K182723	Flexible HD Cysto-Urethroscope System	FAJ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 18, 2019	K183264	Flex-THOR scope	GCJ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
November 20, 2018	K182696	Telepack X LED	FET	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
July 18, 2018	K180977	KARL STORZ New Generation Trocars	GCJ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
April 17, 2018	K180146	KARL STORZ ICG Imaging System	GWG	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
February 2, 2018	K171402	KARL STORZ Slim Nasopharyngolaryngoscope	EOB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 2, 2017	K171717	AUTOCON III 400	GEI	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
July 7, 2017	K162992	Karl Storz UROMAT E.A.S.I.	LJH	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
May 25, 2017	K171238	KARL STORZ ICG Imaging System	OWN	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
May 16, 2017	K170462	KARL STORZ ShuntScope	GWG	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
March 16, 2017	K162880	TIPCAM 1S 3D System	GWG	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
March 2, 2017	K162410	TIPCAM 1S 3D System	EOB	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
January 26, 2017	K162882	KARL STORZ ICG Imaging System	OWN	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
October 21, 2016	K161555	KARL STORZ NAV1 Electromagnetic Navigation System	PGW	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
September 17, 2016	K161112	KARL STORZ Flexible Video-Neuro-Endoscope System	GWG	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
May 31, 2016	K152583	KARL STORZ Endoscopic ICG Imaging System	OWN	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 8, 2016	K150969	Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces	ERL	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
October 23, 2014	K142556	Flexible Video-Uretero-Choledochoscope System	FGB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
September 4, 2014	K140964	CALCULASE II	GEX	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
June 11, 2014	K141250	FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM	FGB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 2, 2014	K131364	FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE	FBO	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
December 20, 2013	K131953	IMAGE1 SPIES	FET	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
November 26, 2013	K131369	FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM	FGB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
June 26, 2013	K122983	KSEA BIPOLAR ELECTRODE	HIN	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 25, 2013	K123956	POWER LED 175	FCW	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
June 28, 2012	K103467	CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM	EOB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
December 13, 2011	K112480	VIEW 1 IMAGING	LLZ	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
August 29, 2011	K103308	AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE	LLZ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
November 15, 2010	K093054	SCALP DURA RETRACTOR, MODEL KS00474	GZT	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
October 18, 2010	K093471	KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP	HRX	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
April 21, 2010	K100195	NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X	GCJ	Substantially Equivalent	Nds Surgical Imaging	accessdata.fda.gov
September 14, 2009	K091968	KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C	FCW	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 18, 2009	K090818	KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS	KCT	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 7, 2009	K071754	NEO-VAGINA SURGERY SET AND ACCESSORIES	HDX	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
December 18, 2008	K082925	XENON-100 SCB LIGHT SOURCE, MODEL 20132620	GCT	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
October 10, 2008	K082046	KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO	FBO	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
May 9, 2008	K072410	KSEA CLEARVISION II, MODEL 40334120	GWG	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
April 9, 2008	K080410	KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522	ODA	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
September 13, 2007	K072387	KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES	EOB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
September 12, 2007	K071437	MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C	HWC	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 30, 2007	K070579	STORZ SLX-F2 STORM TOUCH	LNS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 24, 2007	K071530	KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM	EOQ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
May 31, 2007	K070716	IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL	FET	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
May 22, 2007	K070827	KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120	ODA	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
May 1, 2007	K070752	KSEA MINIATURE ENDOSCOPE, MODEL 11565	EOB	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
February 16, 2007	K062464	MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR	GEI	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 31, 2007	K063585	KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM	FDF	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 17, 2007	K062918	KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM	FBO	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
November 9, 2006	K060907	KARL STORZ VIDEO GASTROSCOPES	FDS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 21, 2006	K061541	KSEA BIPOLAR ELECTROTOME	FAS	Substantially Equivalent	Ksea	accessdata.fda.gov
July 27, 2006	K061180	KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR	GCJ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
January 23, 2006	K052680	CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES	GEX	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
December 19, 2005	K053262	KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES	ERL	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 28, 2010	P050027	KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM	OAY	35	October 14, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 13, 2013	66862	Class II	Terminated	Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotra	KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.	accessdata.fda.gov
November 6, 2013	66823	Class II	Terminated	Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue.	KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.	accessdata.fda.gov
May 31, 2013	65505	Class II	Terminated	27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The c	Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.	accessdata.fda.gov
August 16, 2012	60555	Class II	Terminated	KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the	The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.	accessdata.fda.gov
June 1, 2009	55358	Class II	Terminated	Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).	Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.	accessdata.fda.gov
August 17, 2007	44957	Not yet classified	Terminated	Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT	Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.	accessdata.fda.gov
March 10, 2006	35048	Not yet classified	Terminated	Storz Documentation Cart with Articulating Arm, Model Number 9601F	THE ARTICULATING ARM ON THE CART, WHICH HOLDS THE MONITOR, MAY FALL OFF FROM THE CART DURING MANIPULATION. WHEN IT FALLS, IT COULD HIT THE GROUND OR FALL ON THE PEOPLE/OBJECTS THAT ARE IN CLOSE PROXIMITY.	accessdata.fda.gov

Compare with other makers

Updated October 14, 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.