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
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, ... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve,... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, INC
Feb 22, 2021 EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.... It has been identified that the catheter size on the packaging labeling does not correspond to th... Class II EPIX THERAPEUTICS, 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.