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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
Dec 8, 2020 Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product... A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without be... Class II The Magstim Company Limited
Jun 23, 2020 Neurosign V4 Intraoperative Nerve monitor family of devices. Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and... Class II The Magstim Company Limited
Mar 23, 2020 Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the tr... It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... Class II The Magstim Company Limited
Mar 23, 2020 Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated ... It was identified that there is a potential for the Stim Interconnecting high Voltage Cable locat... Class II The Magstim Company Limited
Oct 25, 2018 HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balanc... Class II The Magstim Company Limited
Sep 28, 2017 Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Pow... Users manuals not supplied with 4800-00T US Rapid Therapy System Class II The Magstim Company Limited

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.