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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
Nov 15, 2018 V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 During in-house testing it was determined that their is a possibility that during a sample run, ... Class II Vital Scientific N.V.
Sep 7, 2018 V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro ... The action is being initiated because the cooling indicator board was improperly installed. This... Class II Vital Scientific N.V.
Jan 18, 2016 V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro ... Instrument stopped working due to a software lockup, and no patient results are produced. Class II Vital Scientific N.V.
Jan 10, 2012 Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automate... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automate... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Us... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.
Jan 10, 2012 Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: aut... The action was initiated due power supply failure. During a power supply failure the instrument... Class II Vital Scientific N.V.

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.