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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
Sep 12, 2018 Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1... Foreign material in product Class II CMP Industries, Llc
Sep 12, 2018 IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml... Foreign material in product Class II CMP Industries, Llc
Apr 28, 2016 IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Apr 28, 2016 IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Mar 2, 2016 IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK... Possible presence of foreign material (rust). Class II CMP Industries, Llc
Nov 18, 2013 IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 ... During the current inspection of CMP Industries, the FDA Investigator discovered that the firm ha... Class II CMP Industries, 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.