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Browse Device Recalls

55 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 55 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 55 FDA device recalls.

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DateProductReasonClassFirm
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.
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.
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.
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.
Aug 28, 2012 PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durha... The instrument may not dispense the specimen onto the pre-poured media resulting in a false negat... 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.