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 Incision & Drainage Tray, Catalog number 900-774. 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 Universal Pack, Catalog number 900-1587. 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 Universal Pack, Catalog number 900-1936. 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 Pack, Catalog number 900-620. Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Tummy Tuck Pack, Catalog #900-3026 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 Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, Catalog # 900-848 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 Plastic Surgery Pack, Catalog number 900-1402. 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 Premium Laparotomy Pack, Catalog number 900-1296. 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 Laminectomy Pack, Catalog number 900-1202. 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 Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Wound Closure Tray II, Catalog number 900-064. 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 Breast Pack Used by medical staff to perform patient care procedures such ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 O.B. Pack, Catalog number 900-645. 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 Minor Laceration Tray, Catalog number 900-1765. 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 Open Heart Pack, catalog #900-2618 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 Foley Catheter Kit, Catalog number 900-1139 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 Laparotomy Pack, Catalog number 900-176. 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 Pery Gyn Pack, Catalog number 900-635. 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 Shoulder Pack, catalog #900-2616 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 Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, catalog #900-2516 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 Universal Drainage Tray, Catalog number 900-032. 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 Hip Orthopedia Pack, Catalog number 900-1835. 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 Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Urology Pack, Catalog # 900-868 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog # 900-660 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 ACDF Pack, catalog #900-2917 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 Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-2038. 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 Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cysto Tur Pack, catalog #900-2899 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 Extremity Arm Pack, catalog #900-2438 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 Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1061. 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 Skin Staple Removal, Catalog number 900-782. 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 Angiography Pack, Catalog number 900-1488. 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 Wound Closure Tray I, Catalog number 900-063. 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 Endovenous Custom Pack, Catalog number 900-1937. 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 O.R. Towels, Catalog number 900-629. Used by medical staff to perform pati... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 OB Pack, Catalog number 900-1717. 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 OB Pack, catalog #900-254 Used by medical staff to perform patient care pr... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Lithotomy Pack, catalog #900-2167 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 900-1091. 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 Cysto Tur Pack, Catalog number 900-430 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 Femoral Pack, catalog #900-2164 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog number 900-403. 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 Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
May 20, 2014 ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15"... Customed has determined that there is the possibility that packaging integrity may be compromised... 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.