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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
Apr 17, 2024 Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended ... X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a fa... Class II NRT X-RAY A/S
Apr 27, 2023 Intelli-C, Right side suspended Tabletop, REF: 03400000 There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... Class II NRT X-RAY A/S
Apr 27, 2023 Intelli-C, Left side suspended Tabletop, REF: 03400010 There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray mac... Class II NRT X-RAY A/S
Jan 21, 2022 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shou... Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down alo... Class II NRT X-RAY A/S

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.