Browse Device Recalls
22 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 22 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 22 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2024 | LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item N... | Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer... | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, p... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, ... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
| Jul 16, 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4,... | The trial stems were manufactured using the wrong design. | Class II | Waldemar Link GmbH & Co. KG (Corp. Hq.) |
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.