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Browse Device Recalls

61 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 61 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 61 FDA device recalls.

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DateProductReasonClassFirm
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Jan 23, 2020 HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... Class I Heartware, Inc.
Jan 23, 2020 HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... Class I Heartware, Inc.
Nov 19, 2018 Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... HVAD Battery Charger units manufactured with wrong inductors. Class II Heartware, Inc.
Aug 28, 2018 Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... Certain HVAD System Controller units may not meet the labeled standard for protection against wat... Class II Heartware, Inc.
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
Jan 7, 2016 HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... Heartware Ventricular Assist System Battery Cell experiencing premature depletion. Class I Heartware, Inc.
Dec 27, 2012 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosen... Class II Heartware 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.