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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 22, 2013 Surgicutt fully automated incision making device for bleeding time determinat... ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; L... Class II ITC-Nexus Dx
Aug 16, 2013 Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... Class II Philips Medical Systems (Cleveland) Inc
Aug 5, 2013 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product co... 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these prod... Class II 3M Company/3m Espe Dental Products
Jul 31, 2013 Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 31, 2013 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio... Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issu... Class II Synthes USA HQ, Inc.
Jul 31, 2013 Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 30, 2013 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT... Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ... Class II Zimmer, Inc.
Jul 30, 2013 Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product ... The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are e... Class II Synthes USA HQ, Inc.
Jul 12, 2013 Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruc... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction,... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reco... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene IFG with Assisted Delivery Intended for use in arterial vascular re... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstr... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruct... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, ... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 8, 2013 GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM... The products were produced using the wrong color material, resulting in the devices being red (u... Class II Smith & Nephew Inc
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 Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized f... Difficulty removing screws from the Invue caddies. Class II SpineFrontier, Inc.
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.