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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Jan 2, 2020 Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; ... A mix-up of autosampler tube positions with a possibility of misidentification of sample results ... Class II Clinical Diagnostic Solutions, Inc.
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Aug 4, 2010 Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as ... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr... Class III Clinical Diagnostic Solutions
Aug 4, 2010 Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a cont... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr... Class III Clinical Diagnostic Solutions

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.