Browse Device Recalls
917 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 917 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 917 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-GN86), REF 413942, 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-P613), REF 410027, 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-P650), IVD, REF 421296, 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-N190), REF 412548, 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-GN74), REF 413941, 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-P645), IVD, REF 419602, 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-P649), IVD, REF 420858, 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 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton... | 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-N345), IVD, REF 420580, 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-N327), IVD, REF 418515, 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-N311), IVD, REF 416952, 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-N348), IVD, REF 420856, 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-P592), REF 22287, 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-XN01), REF 410025, 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-N358), IVD, REF 421441, 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-GN16), REF 22139, 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 Positive Susceptibility card (AST-P584), REF 22252, 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-GN79), REF 413436, 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-GN14), REF 22096, 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-N356), IVD, REF 421352, 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 Positive Susceptibility card (AST-P577), REF 22218, 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 Positive Susceptibility card (AST-GP74), REF 414971, 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-N322), IVD, REF 418489, 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-GN69), REF 413400, 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-N255), REF 413724, 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-P616), REF 410223, 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-GN13), REF 22095, 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-GN66), REF 413398, 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-N276), REF 414286, 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-N235), REF 413170, 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-N223), REF 413110, 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-N216), REF 413066, 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-N290), REF 415058, 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-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 |
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.