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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
May 6, 2024 NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... Class II NovaSignal Corp.
May 6, 2024 NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2 Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrica... Class II NovaSignal Corp.
Dec 16, 2022 Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste... Class II NovaSignal Corp.
Dec 16, 2022 NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of Nova... Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the syste... Class II NovaSignal 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.