Browse Device Recalls
481 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 481 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 481 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 23, 2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with t... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS ... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intend... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 1, 2018 | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is... | Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS... | Class II | bioMerieux, Inc. |
| Jan 26, 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... | Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... | Class I | 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 |
| Jan 4, 2018 | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Jan 4, 2018 | BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) ... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Oct 18, 2017 | NucliSENS Lysis Buffer Extended lot for RES 76675 | Elute may become colored due to the residual presence of heme group origination from hemoglobin p... | Class II | BioMerieux SA |
| 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 |
| May 15, 2017 | VIDAS Testosterone, Ref 30418 | Complaints were received from customers observing falsely overestimate results or external qualit... | Class II | bioMerieux, Inc. |
| Apr 25, 2017 | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a qu... | False susceptible results | Class II | BioMerieux SA |
| 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 |
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.