Browse Device Recalls
1,730 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,730 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 1,730 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 16, 2017 | Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Setup Pack, part number AMS3112(A Product packaged in a convenient manner fo... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Vitrectomy Pack, part number AMS4952 Product packaged in a convenient mann... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a c... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient mann... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | PRK Tray, part number DDS1044 Product packaged in a convenient manner for ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient ... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 16, 2017 | Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, a... | AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential fo... | Class II | Windstone Medical Packaging, Inc. |
| Mar 10, 2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... | In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... | Class I | Heartware |
| Feb 27, 2017 | Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Nu... | Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endura... | Class II | Medtronic Vascular, Inc. |
| Feb 22, 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide c... | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... | Class I | Medtronic Neurosurgery |
| Feb 20, 2017 | Poly Component Trial, MPCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, PS, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, CR, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, UCCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 9, 2017 | SynchroMed II implantable drug infusion pump, Model 8637-40, | Medtronic received a complaint that there was an error code displayed on the programmer when the... | Class II | Medtronic Neuromodulation |
| Feb 8, 2017 | BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 | Handle may break during use. | Class II | Medtronic |
| Feb 8, 2017 | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 | Handle may break during use. | Class II | Medtronic |
| Jan 31, 2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel... | Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro... | Class II | Medtronic Inc. |
| Jan 26, 2017 | Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Ste... | Customer reports of the device handset continuing to operate after release of the activation button. | Class II | COVIDIEN MEDTRONIC |
| Jan 17, 2017 | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Perito... | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between Fe... | Class II | Medtronic Neurosurgery |
| Jan 11, 2017 | Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, pa... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Stem Pack, part number AMS5166 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Hernia Pack, part number AMS3859 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Bayview Abdominoplasty Pack, part number 009079-1 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lower Extremity Pack, part number AMS4669 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lap Gallbladder Pack, part number AMS3707 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Facial Plastic Pack, part number AMS3327(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Universal Pack, part number AMS2036 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Morris Lap Pack, part number PSS3199(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Angio Pack, part number AMS6711 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Brow Pack, part number PSS1785(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Extremity Pack-N Brunswick, part number PSS1866(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic General Pack, part number AMS4215 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Facial Pack , part number AMS6501 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Dr Bragg Vein Tray - RX, part number 007912-8 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Plastic Kit, part number CMP1084(C | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AM... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. | 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 (1185), part number AMS6560 | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part n... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Set Up Pack, part number PSS3574(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Peri GYN, part number PSS2193(A | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | Class II | Windstone Medical Packaging, Inc. |
| Jan 11, 2017 | Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, ... | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... | 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.