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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Sep 17, 2014 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 17, 2014 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Jun 19, 2014 Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Mode... A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads ... Class II Boston Scientific CRM Corp
Aug 29, 2013 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... Class II Boston Scientific CRM Corp
Aug 29, 2013 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... Class II Boston Scientific CRM Corp
Jul 15, 2013 Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable C... Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to... Class II Boston Scientific CRM Corp
Apr 10, 2013 LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE... Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488... Class II Boston Scientific CRM Corp
Mar 1, 2013 Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato... An internal protective fuse can be unintentionally activated while the device is charging its cap... Class II Boston Scientific CRM Corp

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.