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Browse Device Recalls

682 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 682 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 682 FDA device recalls.

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DateProductReasonClassFirm
Jan 7, 2016 Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff t... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by me... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AA... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical sta... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADUL... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff t... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, 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.