Browse Device Recalls
336 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 336 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 336 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 11, 2017 | Bayview Breast Pack, part number 009080-2 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lap Band Pack, part number AMS1785(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Robotic Pack, part number AMS4389 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Eye Plastic Tray, part number PSS1931(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | D & C Kit, part number CMP1466(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Custom Venous Kit, part number TVS4024(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Laparotomy Pack - NS, part number AMS4347 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic P... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | C-Tray Pack, part number PSS2707(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | General Pack, part number AMS2967(A General Pack, part number AMS3239(A Gen... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Arthroscopy Pack, part number AMS6559 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Newport Coast Basic Pack, part number 007484-1 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Basic Setup Tray, part number AMS6414 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | HSG Pack, part number PSS3287 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Laparoscopy Pack (1184), part number AMS6562 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Total Hip Pack, part number PSS2956 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Kit, part number PHC1307(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Transvaginal Pack, part number CMP1767 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Knee Pack, part number AMS4211 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Orbitofacial Pack, part number AMS5850(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Ortho Pack, part number PSS3466(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Major Pack (1345), part number AMS6565 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Surgical Pack, part number PSS3540(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Minor/General/Ortho Pack, part number PSS3258(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | General Surgery Pack, part number PSS1380(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Upper Torso Tray, part number PSS1554(B | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Nasal Pack, part number PSS2186 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Mar 21, 2016 | Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom conven... | These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... | Class II | Windstone Medical Packaging, Inc. |
| Mar 21, 2016 | General Surgery Pack, part number 006880-3. This is a custom convenience sur... | These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... | Class II | Windstone Medical Packaging, Inc. |
| Mar 21, 2016 | Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenien... | These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by ... | Class II | Windstone Medical Packaging, Inc. |
| Nov 2, 2015 | AMS 4674 Custom Pack. For use in a general clinical procedure. | AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinge... | Class II | Windstone Medical Packaging, Inc. |
| Nov 2, 2015 | AMS 4675 Angio Pack. For use in a general clinical procedure. | AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger... | Class II | Windstone Medical Packaging, Inc. |
| Apr 22, 2015 | Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS332... | 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 Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 ... | 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 Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D ... | 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 | HSG Pack, Kit number PSS3287 convenience custom kits used for general surger... | 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 | Hystero Pack, Kit number PSS3535 convenience custom kits used for general su... | 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 Abdominoplasty Pack, Kit part number 009079-1 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 | Custom Venous Kit, TVS4024(C 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 | Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for gen... | 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 | Vaginal Pack, Kit number AMS1722 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 | Surgical Pack, Kit number PSS3540 and PSS3540(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 | Nasal Pack, Kit number PSS2186 convenience custom kits used for general su... | 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 | Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for ge... | 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 | Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience... | 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 Scope Pack, Kit number AMS2498 and AMS2498(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. |
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.