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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

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
Jul 19, 2016 UroDiagnost; x-ray system. Product Code: 708033 The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... Class II Philips Electronics North America Corporation
Jul 19, 2016 Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 ... Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software ver... Class II Thermo Finnigan LLC
Jul 19, 2016 MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036 The two bolts that attach the clamping plate to the lateral shaft may break, which could cause th... Class II Philips Electronics North America Corporation
Jul 18, 2016 MACH Cranial Treon. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 MACH AxiEM Cranial Treon. The software application is sent in CD format with ... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, ... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee repl... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY:... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 Synergy Spine. The software application is sent in CD format with an IFU, wra... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for t... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 Fusion ENT Application. The software application is sent in CD format with an... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the ... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orth... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... Class III Becton, Dickinson and Company, BD Biosciences
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, ... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for th... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 Synergy Cranial S7. The software application is sent in CD format with an IFU... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert... Internal investigation found the certain lots of MRSA kits have the potential for performance iss... Class II Cepheid
Jul 18, 2016 FrameLink. The software application is sent in CD format with an IFU, wrapped... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R,... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X... Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ... Class II Aribex Inc
Jul 18, 2016 BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for t... The adhesive may be inadequately applied or the assembly may be manipulated after application of ... Class II Bovie Medical Corporation
Jul 18, 2016 S7 MACH FrameLink. The software application is sent in CD format with an IFU,... Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... Class II Medtronic Navigation, Inc.
Jul 18, 2016 NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged... Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had ... Class II Aribex Inc
Jul 18, 2016 TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee repl... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 18, 2016 TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orth... The alpha total knee replacement components that may have not been passivated in accordance with ... Class II Medtronic Sofamor Danek USA Inc
Jul 15, 2016 Custom Made Tracheostomy Device The CADD Administration Sets with Flow Sto... Smiths Medical determined that a single custom Tracheostomy device had been shipped to the custom... Class II Smiths Medical ASD, Inc.
Jul 15, 2016 cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: Th... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 312 Pre-Analytical System calculator/data processing module, for cli... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 15, 2016 Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a comput... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clini... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage:... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 RSD 800A Aliquoting System calculator/data processing module, for clinical u... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 612 Pre-Analytical Instrument calculator/data processing module, for... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 15, 2016 cobas p 512 Pre-Analytical Instrument calculator/data processing module, for... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 501 Post-Analytical Unit calculator/data processing module, for clin... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 RSD 800 Sorting System calculator/data processing module, for clinical use ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Affinity Four Birthing Bed Model P3700 The primary packaging is pictured... Class II Hill-Rom, Inc.
Jul 15, 2016 Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The syste... Topcon discovered an anomaly with titration, only when EpM is turned on during the titration proc... Class II Topcon Medical Laser Systems, Inc
Jul 15, 2016 URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: Th... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 MOSAIQ Oncology Information System It is possible that a change to an Order Set will not be saved in the current open Care Plan. Thi... Class II Elekta, Inc.
Jul 15, 2016 VS II Aliquoter System calculator/data processing module, for clinical use ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 701 Post-Analytical Unit calculator/data processing module, for clin... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 cobas p 471 centrifuge unit calculator/data processing module, for clinical ... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 15, 2016 Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Ch... Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2016 Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measu... Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 an... Class II DRG Instruments GmbH

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.