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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

797 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 797 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 797 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 15, 2016 SDMS (SenTec Digital Monitoring System) Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Modu... Class II SenTec AG
Aug 17, 2016 HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... Foreign material found within the driveline connector of the HVAD Pump that could cause increased... Class I HeartWare, Inc
Aug 15, 2016 CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5... Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Syst... Class II Biosense Webster, Inc.
Aug 10, 2016 Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Adm... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Port... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 m... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sam... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Produc... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservo... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Sque... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Nee... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and N... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reser... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Tran... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: T... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, D... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Rese... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 10, 2016 Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: ... ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... Class II ICU Medical, Inc.
Aug 4, 2016 UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 7... Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System t... Class II Beckman Coulter Inc.
Jul 11, 2016 Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U... Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori... Class I Alere San Diego, Inc.
Jun 24, 2016 Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:... There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery... Class I The Anspach Effort, Inc.
Jun 20, 2016 Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when ... Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera h... Class II Karl Storz Endoscopy
Jun 20, 2016 PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control ... Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because o... Class II Medtronic Navigation
Jun 16, 2016 AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Jun 16, 2016 AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu... MultiQuant MD software where under certain conditions a user can be presented with incorrect qua... Class II Ab Sciex
Apr 6, 2016 Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ... If used, the optional Swap feature copies programming parameters from the external pulse generato... Class II Nuvectra
Mar 17, 2016 enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec... The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l... Class II Ortho-Clinical Diagnostics
Feb 24, 2016 Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume... Wrong quantitative results may be displayed in a report from the device, which may potentially le... Class II Ab Sciex
Feb 16, 2016 CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: Th... Siemens found a defective part in their production line which could increase risk of an electrica... Class II Siemens Medical Solutions USA, Inc
Jan 14, 2016 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 ... Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too h... Class II Cardiac Science Corporation
Dec 10, 2015 Flow-i Anesthesia System Product Usage: The indication for the Flow-i Ane... Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit ... Class I Maquet Cardiovascular Us Sales, Llc
Dec 2, 2015 PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01... The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical... Class II Gsi Group Inc
Nov 19, 2015 MOVES System Lithium Polymer Batteries The MOVES System is a portable comp... Batteries found unresponsive after storage, not recognized by main device, and are perpetually en... Class I Thornhill Research Inc
Nov 19, 2015 MOVES System, an emergency ventilator with suction, oxygen concentrator and m... Batteries found unresponsive after storage, not recognized by main device, and are perpetually en... Class I Thornhill Research Inc
Nov 10, 2015 Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: T... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Nov 10, 2015 Reagent Management System (RMS) Dimension EXL with LM Product Usage: Th... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Nov 10, 2015 Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: ... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Nov 10, 2015 Reagent Management System (RMS) Dimension EXL with LM STM Product Usage:... Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... Class II Siemens Healthcare Diagnostics Inc.
Sep 29, 2015 Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class II Medtronic 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.