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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jan 20, 2022 PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for cur... The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. Class II Envisiontec US Llc
Jan 6, 2022 FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... Class II Envisiontec US Llc
Jan 6, 2022 FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... Class II Envisiontec US Llc

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.