Browse Device Recalls
368 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 368 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 368 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N250), REF 413573, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P643), IVD, REF 418671, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN71), REF 413402, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N298), IVD, REF 416004, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N317), IVD, REF 417558, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards pe... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 c... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-XN05), REF 413230, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards pe... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N253), REF 413722, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards pe... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N228), REF 413145, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N263), REF 413755, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 c... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N245), REF 413394, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N246), REF 413395, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N230), REF 413147, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN83), REF 413440, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux 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.