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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Sep 10, 2015 Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... Sterility of device is compromised due to breach in the packaging Class II Smith & Nephew, Inc., Endoscopy Div.
Jul 30, 2013 High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessor... During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigati... Class II Smith & Nephew, Inc., Endoscopy Div.
Apr 4, 2013 Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic... Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... Class II Smith & Nephew, Inc., Endoscopy Div.
Apr 4, 2013 Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of or... Driver does not meet specification, oversized. Driver may not be able to be fully inserted into t... Class II Smith & Nephew, Inc., Endoscopy Div.

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.