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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
Oct 16, 2025 Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed... Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly t... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 The FLUOROspeed is intended to be used as a universal diagnostic imaging syst... X-ray R/F system software with certain versions of the control board may occasionally fail to dis... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 Trinias unity, Digital Angiography System with Catheterization Table, Model: ... If digital angiography system is used with a specific catheterization table and the operator dire... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitabl... X-ray R/F system software with certain versions of the control board may occasionally fail to dis... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Jan 29, 2024 Shimadzu, Trinias, Digital Angiography System Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnorm... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Apr 10, 2023 Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSp... Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing ... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

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.