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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Sep 30, 2020 COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant compo... The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval... Class II Merz North America, Inc.
May 20, 2016 Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Mer... Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. Class II Merz North America, Inc.
Oct 26, 2015 PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable impl... The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... Class II Merz North America, Inc.
Oct 26, 2015 Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated fo... The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... Class II Merz North America, Inc.
Oct 26, 2015 PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) I... The expiration date encoded in the UDI barcode on the label on the product carton and the peelabl... Class II Merz North America, 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.