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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Oct 7, 2025 GM85 Digital Mobile X-ray imaging System; Model Number: GM85; The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture... Class II NeuroLogica Corporation
Jul 8, 2024 GM60A. Digital Diagnostic Mobile X-Ray System. Potential for the anti-fall system of the device arm to fail. Class II NeuroLogica Corporation
Dec 28, 2023 Samsung Digital Diagnostic Mobile X-ray System, Model GM85. Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm d... Class II NeuroLogica Corporation
Jun 6, 2023 OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy tha... 1. Wheels loosening over time with use of the device could lead to the inability to effectively d... Class II NeuroLogica Corporation
Mar 8, 2023 Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray S... Issue related to the operation of the arm latch within the column that supports the arm, potentia... Class II NeuroLogica Corporation
Jul 15, 2020 OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems wi... There are potential issues related to the operational state of the scanner, specifically for tran... Class II NeuroLogica Corporation
Jul 25, 2019 HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03... There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size v... Class II NeuroLogica Corporation
Jul 25, 2019 WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19... There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size v... Class II NeuroLogica Corporation
May 6, 2019 Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85... Potential issue related to the operation of the safety latch within the column that supports the ... Class II NeuroLogica Corporation
Jan 12, 2018 Solid state x-ray imager (flat panel/digital imager) Solid state x-ray i... While transporting the portable machine with the retrofit equipment in a backwards motion, there ... Class II NeuroLogica Corporation
Jun 22, 2017 The GC80 Digital X-ray Imaging System An image was obtained with over exposure during a Thorax examination using the AEC function. Class II NeuroLogica Corporation
May 24, 2017 Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in ... When performing the Stitching function on GU60A system, unintended area is exposed to radiation Class II NeuroLogica Corporation
Sep 14, 2015 Samsung GM60A-40S Intended for use in generating radiographic images of hu... When the system is driving over a non-conductive floor and then over a conductive, grounded part,... Class II NeuroLogica Corporation

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.