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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Sep 12, 2025 Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number:... Due to Users not having access to the Instructions for Use/User Manual due to it being password p... Class II Noah Medical Corporation
Oct 28, 2024 Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of ... Bronchoscopic visualization system power supplies have defective semiconductor components that ma... Class II Noah Medical
Oct 25, 2024 Galaxy System (GAL-001) Bronchoscopic system uninterruptable power may have defective component, may cause power supply s... Class II Noah Medical
Oct 25, 2024 Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: ... Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or eq... Class II Noah Medical
Mar 9, 2024 Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Gal... Due to a misaligned calibration of the wired controller that may result in unintended motion of t... Class II Noah Medical

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.