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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.

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DateProductReasonClassFirm
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 12, 2014 VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6... Calibrator values assigned for the calibrator kit lots were released using a reference method tha... Class II Ortho-Clinical Diagnostics
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class II Microline Surgical, Inc.
May 12, 2014 Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-... One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventil... Class II Summit Medical, Inc.
May 12, 2014 VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number... Calibrator values assigned for the calibrator kit lots were released using a reference method tha... Class II Ortho-Clinical Diagnostics
May 12, 2014 Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system ... Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is... Class II Toshiba American Medical Systems Inc
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusab... Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class II Microline Surgical, Inc.
May 9, 2014 Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90... Class II Spacelabs Healthcare Inc
May 9, 2014 Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Staining on hip implant. Class II Omnilife Science Inc.
May 9, 2014 LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP100... Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK... Class II Physio-Control, Inc.
May 9, 2014 ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton ... Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitor... Class II VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
May 9, 2014 Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobil... There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the or... Class II Siemens Medical Solutions USA, Inc
May 9, 2014 Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da V... Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to ove... Class II Intuitive Surgical, Inc.
May 9, 2014 Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems ar... Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generato... Class II Siemens Medical Solutions USA, Inc
May 9, 2014 CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 1458... There is a potential for inaccuracies in blood gas readings/measurements. There is a potential ri... Class II Terumo Cardiovascular Systems Corporation
May 8, 2014 Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 3115... Straps may separate from the foam pad. Class II Covidien LLC
May 8, 2014 Anspach Pneumatic and Electric Motor Systems. Intended for cutting and sha... Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) wh... Class II The Anspach Effort, Inc.
May 8, 2014 Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia De... A software anomaly causes temperature alarm limits to change to limits which are not physiologica... Class II Spacelabs Healthcare Inc
May 8, 2014 MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. Th... ConMed Corporation has received complaints regarding sparking, no output and burning at the cord ... Class II ConMed Corporation
May 7, 2014 G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument fo... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
May 7, 2014 G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument f... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
May 6, 2014 Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannula... Contains a sharp tip needle when the product should contain a blunt tip cannula Class II Beaver-Visitec International Inc.
May 6, 2014 Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; L... There is a potential risk when using LANTIS OIS System client software with operating systems for... Class II Siemens Medical Solutions USA, Inc
May 6, 2014 Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim ... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 6, 2014 Photonica Light Modulator. These include all products labeled as UltraSlim, L... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 6, 2014 Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim... Marketing without marketing clearance or approval. Class II Advanced Photonic Systems, LLC
May 5, 2014 ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: T... "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marke... Class I DIABETIC SUPPLY OF SUNCOAST, INC.
May 5, 2014 Horizon Medical Imaging It is a medical image and information management a... The firm has identified a software issue which may cause a discrepancy between the index of image... Class II Mckesson Medical Immaging
May 5, 2014 All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R... In spine clinical workflows, cross reference lines may be used to determine the position of slice... Class II Philips Medical Systems, Inc.
May 5, 2014 Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50... When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error ca... Class II Philips Healthcare Informatics, Inc.
May 2, 2014 Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtron... Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP lim... Class II Medtronic Neuromodulation
May 2, 2014 Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer... Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 981... Class II Alere San Diego, Inc.
May 2, 2014 Kenex Radiation Shield and surgical lamps installed with GE Healthcare Inter... GE Healthcare has recently become aware of a potential safety issue due to the improper installat... Class II GE Healthcare, LLC
May 1, 2014 NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with ... Container cap may contain foreign material- 0.60% - 0.80% Manganese Class III Fresenius Medical Care Holdings, Inc.
May 1, 2014 Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE P... Tritanium Patella Inserter Instrument fracture during implantation. . Class II Stryker Howmedica Osteonics Corp.
Apr 30, 2014 Merge Hemo software. Merge Hemo monitors, measures, and records physiolog... The application may crash during the cath lab procedure. Class II Merge Healthcare, Inc.
Apr 30, 2014 IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optic... Failure to effectively install and test a hotfix to correct the known software defect within the ... Class II AGFA Corp.
Apr 30, 2014 Robotic Arm Interactive Orthopedic System (RIO) Revision of the field manual Class II Mako Surgical Corporation
Apr 30, 2014 Varian On-Board Imager Advanced Imaging System. The On-Board Imager device... Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generat... Class II Varian Medical Systems, Inc.
Apr 30, 2014 HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL a... HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calib... Class II Abbott Laboratories
Apr 30, 2014 PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or... Difficulty removing the cup adaptor from the impaction handle during surgery Class II Microport Orthopedics INC.
Apr 29, 2014 Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 ... Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition,... Class I Convatec Inc.
Apr 29, 2014 Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... Events related to a pacing rate outside of the intended setting, including events of sudden incre... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Apr 29, 2014 Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2... Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. Class II Synthes, Inc.
Apr 29, 2014 Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infan... The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring... Class II Childrens Medical Ventures
Apr 28, 2014 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... Class II Baxter Healthcare Corporation
Apr 28, 2014 Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O... Greatbatch identified that the documentation does not support the five-year shelf life of the Bar... Class II Greatbatch Medical
Apr 28, 2014 Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-... Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may... Class II Atrium Medical Corporation
Apr 25, 2014 MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis... There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monit... Class II Siemens Medical Solutions USA, 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.