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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

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
Aug 13, 2014 Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump Sys... An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the ... Class II Maquet Cardiovascular, LLC
Aug 13, 2014 Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use wi... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (... Reports of deterioration of material covering the articulating section of the V5Ms transesophagea... Class II Siemens Medical Solutions USA, Inc.
Aug 13, 2014 JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ... BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th... Class III Biofire Defense
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use w... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 13, 2014 Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... Internal testing had identified a potential breach to the sterile barrier that may impact the ste... Class II Volcano Corporation
Aug 13, 2014 ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers... The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay ... Class II Siemens Healthcare Diagnostics
Aug 13, 2014 Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use w... Disposable Patient Circuit that allows water to leak into the center gas lumen Class II Vapotherm, Inc.
Aug 12, 2014 The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ... Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2014 The Siemens Symbia T series is intended for use by appropriately trained heal... Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2014 AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Lum... It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 o... Class II Siemens Medical Solutions USA, Inc
Aug 12, 2014 PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR3... The device may have a non-conforming component that may cause the device to fire an unformed staple. Class II Ethicon Endo-Surgery Inc
Aug 12, 2014 The Siemens Symbia S series is intended for use by appropriately trained heal... Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2014 eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA... Two (2) failures of the spring link components within the articulated arm assembly. The spring li... Class II Gendex Corp
Aug 11, 2014 ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX P... Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability c... Class II Horiba Instruments, Inc dba Horiba Medical
Aug 11, 2014 Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, P... The firm found that the top cover of the mattresses were delaminating. Class II Primus Medical LLC
Aug 11, 2014 LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group During label reconciliation a duplicate serial number label was detected to be printed for the LI... Class III Datascope Corporation
Aug 11, 2014 Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant)... Product not approved for use in the US Class II Instradent USA, Inc.
Aug 11, 2014 ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ... Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing tha... Class III ELITech Clinical Systems SAS
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is ... Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. Class II Sun Nuclear Corporation
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usag... The firm is distributing the Rejuvenator device without an approved 510(k). Class II Baro-Therapies, Inc
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Philips had discovered through a field service testing where a device failed to comply with a Fe... Class II Philips Medical Systems, Inc.
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Contain... Technical Support Bulletin issued in February 2013 did not mention performance limitation for Pro... Class II Beckman Coulter, Inc.
Aug 8, 2014 CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig... CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven... Class I CareFusion 203, Inc.
Aug 8, 2014 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-s... GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sen... Class II GE Healthcare, LLC
Aug 7, 2014 PERSONA The Personalized Knee System Tibial Articular Surface Provisional Lef... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 Philips IntelliSpace ECG Management System, with software option C61 needed ... Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Q... Class II Philips Medical Systems, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Tibial Articular Surface Pro... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 6, 2014 Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, S... Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes an... Class II Parker Laboratories, Inc.
Aug 6, 2014 iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only... One lot may not have been properly sealed, resulting in a non-sterile device. Class II Ellex iScience, Inc.
Aug 6, 2014 B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... Class II B. Braun Medical, Inc.
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 6, 2014 Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Me... The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline F... Class II Arrow International Inc
Aug 6, 2014 Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Patter... AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to ... Class II Angiodynamics, Inc.
Aug 6, 2014 VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitati... VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower... Class II ORTHO-CLINICAL DIAGNOSTICS

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.