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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Aug 29, 2025 NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalo... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Aug 29, 2025 NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... Potential for breaches in the sterile barrier packaging, compromising sterility assurance. Class II Northeast Scientific Inc.
Apr 26, 2021 NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the eva... 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. Class II Northeast Scientific 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.