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 |
|---|---|---|---|---|
| Mar 16, 2021 | VIDAS¿ CMV IgM 30 Tests | bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM... | Class II | Biomerieux Inc |
| Jan 28, 2021 | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the ext... | bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... | Class II | Biomerieux Inc |
| Jan 28, 2021 | VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with... | bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... | Class II | Biomerieux Inc |
| Mar 11, 2020 | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VI... | There is a potential for the occurrence of false positive OXSF results for some Staphylococcus au... | Class II | Biomerieux Inc |
| Oct 22, 2019 | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Following Customers complaints, investigations have been initiated on potentially false results o... | Class II | Biomerieux Inc |
| Jan 23, 2018 | bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system c... | Missing desiccant. | Class II | Biomerieux Inc |
| Oct 11, 2017 | VITEK2 GP-ID, REF 21342 IVD | Customers have reported, and an internal investigation has confirmed, occurrences of atypical neg... | Class II | Biomerieux Inc |
| Aug 25, 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R)... | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus... | Class II | Biomerieux Inc |
| Jul 12, 2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent card... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jul 12, 2017 | VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| May 16, 2017 | VITEK 2 Gram Negative test kits containing colistin (cs01n) | The investigation demonstrated a high rate of very major errors (resistant isolates calling susce... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 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-N211), REF 413043, 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-P603), REF 22320, 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-N350), IVD, REF 421037, 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-P629), REF 414576, 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-P606), REF 22330, 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-N292), REF 415063, 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-N217), REF 413080, 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-GP71), REF 410750, 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-P621), REF 412533, 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-P644), IVD, REF 418673, 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-N285), REF 414740, 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-N315), IVD, REF 417426, 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-GN82), REF 413439, 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-N363), IVD, REF 421692, 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-N286), REF 414778, 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-GN04), IVD, REF 22000, 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-N354), IVD, REF 421350, 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-N272), REF 414164, 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-N324), IVD, REF 418603, 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 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 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-P640), IVD, REF 418579, 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-N352), IVD, REF 421258, 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-N320), IVD, REF 418204, 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-N233), REF 413117, 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-GN87), REF 413943, 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-N209), REF 412938, 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-GN81), REF 413438, 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-N204), REF 412865, 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-N238), REF 413203, 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-N208), IVD, REF 413062, 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-GN75), REF 413432, 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 identification card (GN), IVD, REF 21341, 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-N215), REF 413065, 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 Fungal Susceptibility card (AST-YS01), REF 22108, 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-N237), REF 413172, 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-N271), REF 414163, 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-GN73), REF 413404, 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-N213), REF 413063, 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.