Browse Device Recalls
225 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 225 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 225 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2022 | GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal HAND PACK, REF 89-10314.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal RETINAL PACK, REF 89-7336.07 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal KIT EXTREMITY PACK, REF 89-8869.09 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SHOULDER PACK, REF 89-9449.13 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal KIT HEART B PACK, REF 89-9042.07 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CATARACT PACK CSM, REF 89-6863 | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been rec... | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal FACIAL PACK PGYBK, REF 89-10007.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal TRANS CANAL PACK, REF 89-7157.12 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal CANNULTED HIP PACK, REF 89-6977.10 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal SHOULDER KIT, REF 89-9497.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal PAIN TRAY, REF 89-10464.03 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal FOOT PACK, REF 89-9252.08 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal VIT RD PACK 86ST, REF 89-7308.09 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11 | XXX | Class II | DeRoyal Industries Inc |
| Nov 3, 2022 | DeRoyal MYELOGRAM PACK, REF 89-9304.05 | XXX | Class II | DeRoyal Industries Inc |
| Aug 12, 2022 | DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors | Procedure packs contained a recalled product. | Class II | DeRoyal Industries Inc |
| Jul 15, 2022 | DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release... | The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap... | Class II | DeRoyal Industries Inc |
| Mar 3, 2022 | DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhex... | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... | Class II | DeRoyal Industries Inc |
| Mar 3, 2022 | DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (ch... | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... | Class II | DeRoyal Industries Inc |
| Mar 3, 2022 | DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine glu... | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods... | Class II | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| Jan 25, 2021 | Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-... | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non... | Class II | DeRoyal Industries Inc |
| Jan 25, 2021 | CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13... | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non... | Class II | DeRoyal Industries Inc |
| Jan 25, 2021 | Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 ... | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non... | Class II | DeRoyal Industries Inc |
| Apr 24, 2020 | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF... | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled... | Class II | DeRoyal Industries Inc |
| Feb 27, 2020 | DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF ... | One lot of product was inadvertently manufactured with a buckle which does not meet the mechanica... | Class II | DeRoyal Industries Inc |
| Nov 21, 2019 | DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3... | The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking. | Class II | DeRoyal Industries Inc |
| Jul 22, 2019 | DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane... | Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the c... | Class II | DeRoyal Industries Inc |
| Jun 18, 2019 | 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... | Class II | DeRoyal Industries Inc |
| Dec 17, 2018 | DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric ... | Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. | Class II | DeRoyal Industries Inc |
| Apr 23, 2018 | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4... | Non-sterile product was packaged inside a case that was labeled as sterile. | Class II | DeRoyal Industries Inc |
| Jan 22, 2018 | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A ... | DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valv... | Class II | DeRoyal Industries Inc |
| Dec 19, 2017 | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray wit... | DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tr... | Class II | DeRoyal Industries Inc |
| Oct 16, 2017 | DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep ... | Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled ... | Class II | DeRoyal Industries Inc |
| Jun 7, 2017 | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... | Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... | Class II | DeRoyal Industries Inc |
| Jan 25, 2017 | SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries Inc |
| Jan 25, 2017 | DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries Inc |
| Nov 7, 2016 | PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,... | DeRoyal received complaints of mold on Tennis Elbow Straps. | Class II | DeRoyal Industries Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.