Browse Device Recalls
813 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 813 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 813 FDA device recalls in PR.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 8, 2014 | Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staf... | 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 900-1393. 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 | Angiography Pack, catalog #900-210 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 | Cysto Tur Pack, Catalog number 900-080. 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 | Orthopedic Pack, catalog #900-2830 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 | 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 |
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.