Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2015 | Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits u... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits us... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Knee Pack, Kit number AMS4211 convenience custom kits used for general surge... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience cu... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, P... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Basin Pack, kit number AMS2497 convenience custom kits used for general sur... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L c... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Cath Pack, kit number AMS4283 convenience custom kits used for general sur... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custo... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Liposuction Pack, Kit number AMS3323 convenience custom kits used for gene... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kit... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Body Contour Pack, Kit part number PSS1749 convenience custom kits used fo... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Laparotomy Tray, Kit number PSS1538 convenience custom kits used for gener... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Hall SAP, Kit number SRK1031(A convenience custom kits used for general surg... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, P... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Universal Pack, Kit number AMS2036 convenience custom kits used for genera... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom k... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Mok Eye Pack, Kit number PSS2640 convenience custom kits used for genera... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Face Pack, Kit number AMS3641 convenience custom kits used for general sur... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, P... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Robotic Pack, Kit number AMS4389 convenience custom kits used for general ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Major Breast Pack, Kit number AMS3409 convenience custom kits used for gener... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for gene... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom k... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... | Class II | Windstone Medical Packaging, 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.