Data / Medical devices / United States / Deroyal Industries, Inc.
Deroyal Industries, Inc.: FDA-registered device maker in Powell, TN, United States, 351 510(k) clearances
Deroyal Industries, Inc. is registered with the FDA (registration 1043214) in Powell, TN, United States. It lists 357 device types. The FDA files 351 510(k) clearances under its listings, the newest dated November 21, 2025. 51 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1043214
- Address
- 200 Debusk LN., Powell, TN, United States, 37849
- Owner or operator
- DEROYAL INDUSTRIES, INC. (1044833)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 3, 1991
- Registered through
- 2026
- Brand names listed
- Absorber, Saliva, Paper - DeRoyal, Accessories, Catheter - DeRoyal, Accessories, Cleaning Brushes, for Endoscope - DeRoyal, Accessories, Operating-Room, Table (Kit) - DeRoyal, Accessories, Traction - DeRoyal, Accessory Equipment, Cardiopulmonary Bypass - DeRoyal, Accessory Surgical Apparel - DeRoyal, Accessory, Surgical Apparel - DeRoyal and more
Devices it lists
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 351.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2025 | K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | OMP | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| April 18, 2024 | K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| March 25, 2024 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | DYB | Substantially Equivalent | Cook Medical | accessdata.fda.gov |
| July 21, 2021 | K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| December 23, 2020 | K200631 | DeRoyal Temperature Monitoring Probe | FLL | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| October 15, 2020 | K200757 | Foley Catheter with Temperature Sensor | EYC | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| October 11, 2020 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | LZC | Substantially Equivalent | 0 & M Halyard, Inc. | accessdata.fda.gov |
| July 29, 2020 | K201361 | PNEUMOCLEAR | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| April 6, 2020 | K193217 | SensiCare PI and SensiCare PI Micro Surgical Gloves | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| April 2, 2020 | K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | FMT | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| April 2, 2020 | K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | BZT | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| March 21, 2020 | K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | FXY | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| March 16, 2020 | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| February 28, 2020 | K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) | KGO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| January 21, 2020 | K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | FMT | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| December 13, 2019 | K192362 | Aero Blue Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| September 6, 2019 | K182751 | Reusable Temperature Probe | FLL | Substantially Equivalent | Shenzhen Caremed Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 1, 2019 | K183413 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifeciences, LLC | accessdata.fda.gov |
| November 2, 2018 | K182096 | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Owens & Minor Halyard, Inc. | accessdata.fda.gov |
| October 30, 2018 | K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| July 2, 2018 | K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | FRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| May 31, 2018 | K170703 | Single Use Arthroscopic Electrode (with Pencil) | HRX | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| April 4, 2018 | K173072 | Algidex Ag Silver Alginate Wound Dressing | FRO | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| March 9, 2018 | K171764 | Fixed Core Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| January 31, 2018 | K173601 | Merit Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 21, 2017 | K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing | FRO | Substantially Equivalent | 3M Company, 3M Healthcare | accessdata.fda.gov |
| August 17, 2017 | K171475 | DeRoyal Laprador Specimen Retrieval System | GCJ | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| April 28, 2017 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | OMP | Substantially Equivalent | Vr Medical Technologies, LLC | accessdata.fda.gov |
| February 8, 2017 | K161432 | MyNeWT Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Stortford Medical, LLC | accessdata.fda.gov |
| April 21, 2016 | K152059 | Disposable General Electrode | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| April 13, 2016 | K160693 | Neptune E-SEP Smoke Evacuation Pencil | GEI | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| April 8, 2016 | K143612 | LifeCare PCA Infusion System | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| March 25, 2016 | K152978 | DeRoyal Angiography Kits | DXT | Unknown | Deroyal Industries, Inc. | accessdata.fda.gov |
| October 26, 2015 | K151182 | LiquiBand Exceed | MPN | Substantially Equivalent | Advanced Medical Solutions (Plymouth), Ltd. | accessdata.fda.gov |
| October 22, 2015 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | MPN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 20, 2015 | K150160 | Temple Touch Pro (TTP) Non-invasive temperature monitoring system | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| September 10, 2015 | K151649 | Valleylab FT10 Electrosurgical Platform | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 21, 2014 | K134006 | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| August 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 25, 2014 | K141311 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 8, 2013 | K132224 | UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES | GEI | Substantially Equivalent | Unimed Surgical Products, Inc. | accessdata.fda.gov |
| October 3, 2013 | K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST | GEI | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| August 22, 2013 | K130027 | DISPOSABLE NEUTRAL ELECTRODE GP202 | GEI | Substantially Equivalent | Cathay Manufacturing Corp. | accessdata.fda.gov |
| April 24, 2013 | K130896 | VASCULAR PROBE, VASCULAR PROBE ES | DWP | Substantially Equivalent | Synovis Life Technologies, Inc. | accessdata.fda.gov |
| March 27, 2013 | K123762 | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 10, 2012 | K112110 | STERILE LUBRICATING JELLY | KMJ | Substantially Equivalent | Jianerkang Medical Dressing Company | accessdata.fda.gov |
| April 5, 2012 | K120570 | CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM | MQP | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| January 19, 2012 | K112300 | KIMGUARD SMART-FOLD* STERILIZATION WRAP | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| January 5, 2012 | K112458 | PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM | OMP | Substantially Equivalent | Medica-Rents Co., Ltd. | accessdata.fda.gov |
| December 20, 2011 | K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT | GEI | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
| October 25, 2011 | K111825 | ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS | GDW | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| October 14, 2011 | K112694 | EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER | DXC | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 1, 2011 | K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| August 19, 2011 | K111441 | UNIMAX VERESS NEEDLE | HIF | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| July 19, 2011 | K110443 | BD INSYTE AUTOGUARD BC | FOZ | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| June 10, 2011 | K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | FMF | Substantially Equivalent | Dmc Medical, Ltd. | accessdata.fda.gov |
| May 20, 2011 | K102946 | CORELEADER COLLA-PAD MODEL CS 03030 | KGN | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| March 3, 2011 | K093830 | MEDLINE ANGIOGRAPHIC CONTROL SYRINGE | DXT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| December 13, 2010 | K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | FPD | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| November 15, 2010 | K102204 | CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| November 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| November 8, 2010 | K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS | FPA | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| September 8, 2010 | K102032 | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 1, 2010 | K101669 | THERMODILUTION CATHETER | DQO | Substantially Equivalent | Biosensors Intl. Pte. , Ltd. | accessdata.fda.gov |
| June 3, 2010 | K094056 | HOTDOG MULTI FUNCTION CONTROLLER | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| March 19, 2010 | K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| February 26, 2010 | K093203 | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 | GEI | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| January 7, 2010 | K093349 | MEDLINE CURAD WOUND DRESSINGS | FRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| December 22, 2009 | K093025 | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES | GEI | Substantially Equivalent | Bovie Medical Corporation | accessdata.fda.gov |
| December 22, 2009 | K091926 | CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM | KWQ | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| December 10, 2009 | K092807 | HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| November 19, 2009 | K092503 | RADAR VASCULAR COMPRESSION DEVICES | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| November 12, 2009 | K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | FYA | Substantially Equivalent | A Plus International, Inc. | accessdata.fda.gov |
| November 2, 2009 | K091531 | CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER | ODP | Substantially Equivalent | Choice Spine, Llp | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| September 11, 2009 | K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | GEI | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| September 9, 2009 | K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | HIB | Substantially Equivalent | Obp Corporation | accessdata.fda.gov |
| August 21, 2009 | K091306 | AMSURE PVC INTERMITTENT CATHETER | EZD | Substantially Equivalent | Amsino International, Inc. | accessdata.fda.gov |
| May 1, 2009 | K082554 | KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 | FRG | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| April 1, 2009 | K090759 | BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM | JCX | Substantially Equivalent | Biodrain Medical, Inc. | accessdata.fda.gov |
| March 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 21, 2008 | K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| October 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| September 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| August 12, 2008 | K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | GEI | Substantially Equivalent | Xodus Medical, Inc. | accessdata.fda.gov |
| June 25, 2008 | K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| May 23, 2008 | K081169 | AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR | GCJ | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| February 7, 2008 | K073438 | PROSTIM 1000/2000 | GZJ | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| December 7, 2007 | K070558 | BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 24, 2007 | K070432 | GENERAL SURGERY DRAPES | KKX | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| July 16, 2007 | K070936 | WELMED HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| May 24, 2007 | K070431 | WELMED, INC. SURGICAL GOWNS | FYA | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| March 26, 2007 | K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | EZL | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| September 25, 2006 | K061422 | SURGICAL DRAPES | KKX | Substantially Equivalent | Austin Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | 99728 | Class II | Ongoing | REF: 81-030415 Myocardial Probe Non-Pyrogenic, 400 Series | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. | accessdata.fda.gov |
| May 18, 2026 | 99044 | Class II | Ongoing | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) | Sterile wound dressing, lacks sterility assurance | accessdata.fda.gov |
| January 31, 2025 | 96261 | Class II | Ongoing | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement | Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care. | accessdata.fda.gov |
| January 15, 2025 | 96130 | Class II | Ongoing | DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care. | accessdata.fda.gov |
| October 3, 2024 | 95509 | Class II | Ongoing | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released. | accessdata.fda.gov |
| February 13, 2024 | 94129 | Class I | Ongoing | GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. | accessdata.fda.gov |
| November 22, 2023 | 93520 | Class II | Ongoing | DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. | accessdata.fda.gov |
| September 18, 2023 | 93078 | Class II | Ongoing | DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe. | accessdata.fda.gov |
| May 30, 2023 | 92445 | Class II | Ongoing | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '8 | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | accessdata.fda.gov |
| April 17, 2023 | 92299 | Class II | Ongoing | Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital | The custom procedure packs contain light handle covers that have been recalled by another firm. | accessdata.fda.gov |
| February 9, 2023 | 91760 | Class II | Ongoing | DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B | The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum. | accessdata.fda.gov |
| December 12, 2022 | 91331 | Class II | Terminated | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach. | accessdata.fda.gov |
| November 28, 2022 | 91287 | Class II | Terminated | DeRoyal Tonsillectomy Tray, REF 89-10698.01 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use. | accessdata.fda.gov |
| November 3, 2022 | 91134 | Class II | Ongoing | DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | accessdata.fda.gov |
| August 12, 2022 | 90749 | Class II | Terminated | DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors | Procedure packs contained a recalled product. | accessdata.fda.gov |
| July 15, 2022 | 90629 | Class II | Terminated | DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; a | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure. | accessdata.fda.gov |
| March 3, 2022 | 89737 | Class II | Terminated | DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection. | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. | accessdata.fda.gov |
| May 14, 2021 | 87949 | Class I | Terminated | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine | accessdata.fda.gov |
| January 25, 2021 | 87218 | Class II | Terminated | CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades. | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker. | accessdata.fda.gov |
| April 24, 2020 | 85594 | Class II | Terminated | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging. | accessdata.fda.gov |
| February 27, 2020 | 85102 | Class II | Terminated | DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint. | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device. | accessdata.fda.gov |
| November 21, 2019 | 84364 | Class II | Ongoing | DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP | The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. | accessdata.fda.gov |
| July 22, 2019 | 83411 | Class II | Terminated | DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Fee | Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube. | accessdata.fda.gov |
| June 18, 2019 | 83154 | Class II | Terminated | DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack | Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product. | accessdata.fda.gov |
| December 17, 2018 | 81818 | Class II | Terminated | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician | Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. | accessdata.fda.gov |
| April 23, 2018 | 79939 | Class II | Terminated | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical | Non-sterile product was packaged inside a case that was labeled as sterile. | accessdata.fda.gov |
| January 22, 2018 | 79052 | Class II | Terminated | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy | DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve. | accessdata.fda.gov |
| December 19, 2017 | 78843 | Class II | Terminated | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Should | DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label. | accessdata.fda.gov |
| October 16, 2017 | 78517 | Class II | Terminated | DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) | Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date. | accessdata.fda.gov |
| June 7, 2017 | 77519 | Class II | Terminated | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure. | Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility | accessdata.fda.gov |
| January 25, 2017 | 76359 | Class III | Terminated | DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN. | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products. | accessdata.fda.gov |
| November 7, 2016 | 75665 | Class II | Terminated | TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis | DeRoyal received complaints of mold on Tennis Elbow Straps. | accessdata.fda.gov |
| August 11, 2016 | 74927 | Class II | Terminated | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit. | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility. | accessdata.fda.gov |
| October 14, 2015 | 72454 | Class II | Terminated | HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. | DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system. | accessdata.fda.gov |
| September 10, 2015 | 72574 | Class II | Terminated | DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) | These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch. | accessdata.fda.gov |
| August 31, 2015 | 72098 | Class II | Terminated | DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; | Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization. | accessdata.fda.gov |
| April 27, 2015 | 71294 | Class II | Terminated | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRAC | Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes | accessdata.fda.gov |
| April 17, 2015 | 71193 | Class II | Terminated | DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue fro | The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. | accessdata.fda.gov |
| August 22, 2014 | 69319 | Class II | Terminated | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only g | These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. | accessdata.fda.gov |
| June 4, 2014 | 68744 | Class II | Terminated | DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc. | The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira. | accessdata.fda.gov |
| February 21, 2014 | 67686 | Class II | Terminated | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themsel | Moldy smell in product | accessdata.fda.gov |
| January 16, 2014 | 67442 | Class II | Terminated | DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries. | Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely. | accessdata.fda.gov |
| August 12, 2013 | 66608 | Class II | Terminated | DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. | accessdata.fda.gov |
| July 15, 2013 | 65764 | Class II | Terminated | DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflat | DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device. | accessdata.fda.gov |
| May 30, 2013 | 65554 | Class II | Terminated | GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical | DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization. | accessdata.fda.gov |
| June 16, 2012 | 62457 | Class II | Terminated | Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits | Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. | accessdata.fda.gov |
| January 20, 2012 | 61434 | Not yet classified | Terminated | DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood | Device's needle may become dislodged from the cup during shipment or during use. | accessdata.fda.gov |
| June 14, 2011 | 60852 | Not yet classified | Terminated | Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; | Custom surgical kits contain recalled Kimberly Clark surgical drapes which were found to contain metal shavings in the folds of the drapes. | accessdata.fda.gov |
| July 1, 2010 | 56682 | Not yet classified | Terminated | NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 Most commonly used during medical medical e | Suction canisters may crack during use | accessdata.fda.gov |
| December 9, 2009 | 54113 | Not yet classified | Terminated | DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit. | Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility | accessdata.fda.gov |
| October 1, 2008 | 49553 | Not yet classified | Terminated | DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit) | Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges. | accessdata.fda.gov |
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Updated September 22, 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.