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 | Face Lift, Catalog number 900-3083. 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 Premium Pack, Catalog number 900-1803. 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 | Minor Laparotomy Pack, Catalog number 900-1735. 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 | Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical ... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to pe... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparoscopy Colorectal Surgical Pack, catalog #900-2259A Used by medical s... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to pe... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Surgical packs (includes trays, bags and kits) 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 | D&C Laparoscopy Pack, Catalog number 900-1496. 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 | Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Reyito Urological Pack, Catalog number 900-1460. 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 | Urology Pack, catalog #900-2510 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 | Arthroscopy Pack, catalog #900-2609 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 | Shoulder Pack, catalog #900-2766 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 | 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 |
| 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 | 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 | 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 900-1042. 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | , 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.