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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-ST... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push ... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapa... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparo... Product coatings require 510K approval. Class II Progressive Medical Inc
Dec 9, 2011 Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), R... Some of the sterile packages had broken seals. Class II Progressive Medical Inc
Oct 28, 2011 Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), R... The tip of the product could come loose or unravel. Class II Progressive 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.