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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient car... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Suction Catheter Kit, Catalog number 900-277. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by med... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical st... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Plastic Surgery Pack, Catalog # 900-920 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 Urology Pack, Catalog number 900-1742. Used by medical staff to perform pa... 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 900-2004. 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 Wound Management Tray, Catalog number 900-1903. Used by medical staff to p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Liposuction Pack, Catalog #900-3028 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 Ear Pack, catalog #900-2234 Used by medical staff to perform patient care ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 D&C Laparoscopy Pack, Catalog number 900-1476. 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 900-474. Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 ENT Pack, Catalog number 900-1482. Used by medical staff to perform patien... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perf... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 General Line Full Body Drape, catalog #900-2262 Used by medical staff to p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Wound Management Tray II, Catalog number 900-1198. Used by medical staff t... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Wound Management Tray, Catalog number 900-1154. Used by medical staff to p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 , Catalog # 900-913 Used by medical staff to perform patient care procedur... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Higado & Pancrea Pack, Catalog number 900-1966. Used by medical staff to p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Ophtalmic Pack, Catalog number 900-1933. 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 Chole Pack, Catalog number 900-1059. 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 Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 OB Pack, Catalog number 900-1030. Used by medical staff to perform patient... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Hip & Knee Replacement, catalog #900-2614 Used by medical staff to per... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cirugia Cardiovascular Case Cart, Catalog number 900-1500. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. Used b... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perfo... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Utility Drape End Product, Catalog number 900-582. Used by medical staff t... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Arthroscopy Pack, Catalog number 900-1832. 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 Arthroscopy Pack, Catalog # 900-902 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 Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform pat... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I 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.