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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 22, 2024 Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended t... Complaints of unexpected detachment of the collimator have been reported. Class II Mirion Technologies (Capintec), Inc.
Apr 22, 2024 Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform ... Complaints of unexpected detachment of the collimator have been reported. Class II Mirion Technologies (Capintec), Inc.
Apr 22, 2024 Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Up... Complaints of unexpected detachment of the collimator have been reported. Class II Mirion Technologies (Capintec), Inc.
Nov 27, 2023 Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear M... Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall dow... Class II Mirion Technologies (Capintec), 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.