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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

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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
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
Jun 19, 2013 Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A,... The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect... Class II Philips Healthcare Inc.
Jun 19, 2013 Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands ar... Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particul... Class II Edwards Lifesciences, LLC
Jun 17, 2013 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 17, 2013 Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 14, 2013 Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 11, 2013 Synthes Flexible Medullary Reamer. Intended to be used to facilitate the p... Due to the coiled design for this product, the product is difficult to clean and the potential fo... Class II Synthes USA HQ, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provi... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provi... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Prov... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provi... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 10, 2013 Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio... Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... Class II Zimmer, Inc.
Jun 7, 2013 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597001131 Femur CR PRC SURF HDN FEM CO-N... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 0059500... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-F... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 005... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; ... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, Inc.
Jun 7, 2013 00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597... Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... Class II Zimmer, 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.