Browse Device Recalls

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

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DateProductReasonClassFirm
Oct 8, 2014 Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Open Heart Tray, Catalog number 900-170. Used by medical staff to perform ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Gyn Pack, Catalog number 900-605. Used by medical staff to per... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog # 900-851 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Major Lap Pack, Catalog number 900-404. Used by medical staff to perform p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Neuro Pack, Catalog number 900-1146. Used by medical staff to perform pati... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-610. Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Retina Pack, Catalog number 900-1611. Used by medical staff to perform pat... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staf... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to pe... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Fanfold Drape, Catalog number 900-633. Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Total Hysterectomy, catalog #900-2415 Used by medical staff to perform pat... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Open Heart Tray, Catalog number 900-1196C Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Extremity PACK, catalog #900-2615 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien ... Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... A software issue may lead to ventilator inoperative situations. Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Sep 20, 2014 Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. ... TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be... Class I Trivascular, Inc
Sep 18, 2014 Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pr... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation E... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number:... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC

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.