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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

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Jun 12, 2013 VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog numbe... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog numbe... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 ... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog num... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 105318... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
Jun 12, 2013 The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibril... The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to... Class II Physio Control, Inc.
Jun 12, 2013 Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV.... An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what w... Class II Accelerated Care Plus Corporation
Jun 12, 2013 VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog numb... Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... Class II Ortho-Clinical Diagnostics
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 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
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 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit R... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ra... The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard... Class II Philips Healthcare Inc.
Jun 11, 2013 AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cab... The RITA Main Cable product contains the incorrect Instructions for Use. Class II Angiodynamics, INC
Jun 11, 2013 Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12m... The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4... Class II Zimmer, Inc.
Jun 11, 2013 The Centricity PACS Workstation is intended for use as a primary diagnostic a... GE has recently become aware of potential issues due to out of context issues associated with spe... Class II GE Healthcare It
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Pro... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
Jun 11, 2013 Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... Class II Integra LifeSciences Corp.
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 pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, O... RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner sol... Class II Radiometer America 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 Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product ... One of the dental implants do not have the internal hex feature. One of the dental implants do n... Class II Biomet 3i, LLC
Jun 10, 2013 StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single U... BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices... Class II Bard Access Systems
Jun 10, 2013 Afinity CQ2015A Intraocular Lens The visual correction of aphakia in perso... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
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 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 syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo... Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the s... Class II Siemens Medical Solutions USA, 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 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 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 SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used... Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Jun 10, 2013 Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant ... One of the dental implants do not have the internal hex feature. One of the dental implants do n... Class II Biomet 3i, LLC
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 nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of a... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
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 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 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.

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.