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Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

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DateProductReasonClassFirm
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number:... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Produ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a w... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Produc... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Produc... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a wa... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Numb... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Produ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a wat... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Produc... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a wa... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a w... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is ... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company
Jun 21, 2013 LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Numbe... Product contains particulates (fibers) Class II Genzyme Corporation, A Sanofi Company

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.