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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
Oct 18, 2019 Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" ... Failed to meet USP minimum average value for knot pull (tensile) strength. Class II CP Medical Inc
Feb 4, 2019 Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per bo... Potential compromise of product sterility after routine monitoring for Endotoxins showed an out o... Class II CP Medical Inc
Feb 2, 2017 PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Me... The tensile strength minimum as directed by USP <881> was not met over the length of the product'... Class II CP Medical Inc
Sep 22, 2014 Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; ... CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorb... Class II C P Medical, 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.