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 |
|---|---|---|---|---|
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer appl... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer applicati... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Nov 3, 2015 | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ... | MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the p... | Class II | bioMerieux, Inc. |
| Jun 12, 2015 | Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. | QC results were out of range resulting in false resistant strains. | Class II | BioMerieux SA |
| Apr 14, 2015 | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer applicat... | The MYLA¿ server could slow down due to the volume (weight) of the data to manage and it could... | Class II | bioMerieux, Inc. |
| Mar 27, 2015 | Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | Class II | Biomerieux Inc |
| Mar 27, 2015 | Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton,... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. | Class II | Biomerieux Inc |
| Mar 27, 2015 | Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | Class II | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Mar 6, 2014 | API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 6, 2014 | FB Reagent (REF 70562). FB reagent is an additional test used for revealin... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 6, 2014 | API Listeria (REF 10300). ZYM B reagent is used and included inside of API... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Mar 6, 2014 | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB ... | Class II | BioMerieux SA |
| Feb 10, 2014 | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medic... | The firm has determined the product may fail to dispense the sample to the agar plate resulting i... | Class II | Biomerieux Inc |
| Nov 8, 2013 | ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reve... | bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin... | Class II | Biomerieux France Chemin De L'Or |
| Nov 8, 2013 | API Listeria (REF 10300) API Listeria is a standardized system for the ide... | bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin... | Class II | Biomerieux France Chemin De L'Or |
| Nov 8, 2013 | API NH (REF 10400) API NH is a standardized system for the identification ... | bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin... | Class II | Biomerieux France Chemin De L'Or |
| Oct 14, 2013 | VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measure... | Product is not approved or authorized for distribution in the US. | Class II | BioMerieux SA |
| Sep 6, 2013 | chromID Salmonella Agar, Reference No. 43621. A selective isolation and di... | Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colo... | Class II | bioMerieux, Inc. |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Apr 17, 2013 | VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrum... | Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefor... | Class II | BioMerieux SA |
| Feb 18, 2013 | VITEK 2 Compact computer system when equipped with the following Hewlett-Pack... | There is a potential to link an isolate result to the wrong patient and then upload the results t... | Class II | Biomerieux Inc |
| Feb 18, 2013 | VITEK 2 XL computer system when equipped with the following Hewlett-Packard P... | There is a potential to link an isolate result to the wrong patient and then upload the results t... | Class II | Biomerieux Inc |
| Feb 18, 2013 | VITEK 2 60 computer system when equipped with the following Hewlett-Packard P... | There is a potential to link an isolate result to the wrong patient and then upload the results t... | Class II | Biomerieux Inc |
| Feb 6, 2013 | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. ... | The product package did not contain the correct version of the package insert listing the limitat... | Class II | Biomerieux Inc |
| Dec 25, 2012 | BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is in... | BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. | Class II | bioMerieux, Inc. |
| Oct 17, 2012 | 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: T... | The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Sa... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | 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.