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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Tracheotomy Care Kit, Catalog number 900-110. 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 | Angiodrape Pack, Catalog number 900-002. 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 #900-2473 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 | Laparoscopy OB GYN Pack, Catalog number 900-1192. 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 Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by ... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medica... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | General Minor Pack, Catalog # 900-787 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 | Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 ... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Premium Cesarean Pack, Catalog number 900-1294 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 | Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Ophtalmic Pack, Catalog number 900-1780. 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 | Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medic... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Cesarean Pack, Catalog number 900-410. 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 | Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparoscopy Pack, Catalog number 900-028. 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 | C-Section Pack, Catalog # 900-998 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 | Dressing Change, Catalog number 900-1538. 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 | Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perf... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Urology Pack, Catalog number 900-1738. 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 | Cesarean Pack, Catalog number 900-1719. 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 | Pery GYN Surgical Pack, Catalog number 900-548A. Used by medical staff to ... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Foley Catheter Kit, Catalog number 900-1127. 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 | Neuro Pack, catalog #900-2256 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 | O.B. Pack, Catalog number 900-012. 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 | Arthroscopy Pack, Catalog number 900-1062. 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 | Surgical Pack, catalog #900-2224 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 | Orthopedic tray, Catalog number 900-1985 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 | Urology Pack, Catalog number 900-1521. 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 | Minor Pack, catalog #900-2511 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 | Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform ... | 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.