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.

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DateProductReasonClassFirm
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Ca... Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. a... Class II Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 ca... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Nov 23, 2015 Granada Biphasic Broth The product is a selective medium for the screening... FDA has determined that the product requires 510(k) clearance to continue marketing/distribution ... 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
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
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
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
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
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument T... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, ... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrume... 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.