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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Jul 26, 2013 Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1... The operators manual does not fully describe the sequence of expected events that will occur when... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System ... The operators manual does not fully describe the sequence of expected events that will occur when... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan... TCVS is taking action to update the Operators Manual with the specific instructions to respond to... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovas... Medical device used in cardiovascular procedures is defective. Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2013 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan... TCVS is taking action to update the Operators Manual with the specific instructions to respond to... Class II Terumo Cardiovascular Systems Corporation
Jul 25, 2013 Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... Review of on-system electronic product labeling and Instructions for comply with applicable Use i... Class II Medtronic Navigation, Inc.
Jul 24, 2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... Class II Gyrus Medical, Inc
Jul 24, 2013 Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104... Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they... Class II Nestle HealthCare Nutrition
Jul 23, 2013 DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L... Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un... Class II Microgenics Corp
Jul 18, 2013 Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... Class II Aspen Surgical Products, Inc.
Jul 17, 2013 Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalo... Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due ... Class II Arrow International Inc
Jul 17, 2013 Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90... Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System... Class II Hospira Inc.
Jul 17, 2013 Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Cat... The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW... Class II Arrow International Inc
Jul 16, 2013 Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... Class III Zoll Circulation, 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 Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-ster... PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Mar... Class II Precision Dynamics Corporation
Jul 10, 2013 Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A... TempaDot products may have been mislabeled. Class II Medical Indicators, Inc.
Jul 9, 2013 Tray Surgical, ENT (various instrument trays) Used for stot age and transp... The firm will recall and replace the identified instrument trays in the field, with trays that ha... Class II Medtronic Xomed, Inc.
Jul 8, 2013 Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 28, 2013 Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart... Class II Medtronic Neurosurgery
Jun 24, 2013 Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat... The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner... Class II Stryker Neurovascular
Jun 21, 2013 Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surg... The outer box label of the product was labeled with a down revision label which did not include t... Class II Myoscience Inc
Jun 19, 2013 Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Pro... Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots Class III Beekley Corporation
Jun 18, 2013 ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for v... Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant -... Class II Aesculap, Inc.
Jun 18, 2013 CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per ca... There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord s... Class II Invacare Corporation
Jun 13, 2013 BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\ki... In vitro diagnostic test kit may exhibit invalid internal negative control results. Class II Becton Dickinson & Co.
Jun 12, 2013 Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 11, 2013 Sodium Bicarbonate, USP Provided bulk as raw material - label not applicabl... Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Ol... Class II Church & Dwight Inc
Jun 10, 2013 Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL ... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Pr... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 E... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriT... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., 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.