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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

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Feb 3, 2015 Philips Healthcare Allure BiPlane Series: Model 722013 Allura X... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper cardio systems Model : 722123 Product Usage: T... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper vascular system Model : 722124 Product Usage: ... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usa... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usa... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usag... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Jan 27, 2015 ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catal... ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... Class II Siemens Healthcare Diagnostics, Inc
Jan 27, 2015 ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic C... ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... Class II Siemens Healthcare Diagnostics, Inc
Jan 27, 2015 ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catal... ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... Class II Siemens Healthcare Diagnostics, Inc
Jan 26, 2015 Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. ... Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are out... Class II Haemonetics Corporation
Jan 23, 2015 Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Mode... Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installatio... Class II Philips Medical Systems, Inc.
Jan 22, 2015 Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use wit... Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... Class II Siemens Healthcare Diagnostics Inc
Jan 22, 2015 Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use wi... Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... Class II Siemens Healthcare Diagnostics Inc
Jan 22, 2015 Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For us... Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 103223... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 30, 2014 RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 106968... Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration ... Class II Siemens Healthcare Diagnostics Inc
Dec 23, 2014 HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ... MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to b... Class II Philips Medical Systems, Inc.
Dec 19, 2014 Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL100... Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope Class II Fresenius Medical Care Holdings, Inc.
Dec 19, 2014 Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i... Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification Class II Philips Medical Systems, Inc.
Dec 19, 2014 lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 A crack may develop in the handle to the Inline Persuader, which may progress if the user continu... Class II SpineFrontier, Inc.
Dec 16, 2014 ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following mach... Unqualified power assemblies shipped to customers. Class II Fresenius Medical Care Holdings, Inc.
Dec 8, 2014 Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomograph... There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Im... Class II Mobius Imaging, LLC
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... Class I Magellan Diagnostics, Inc.
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... Class I Magellan Diagnostics, Inc.
Nov 24, 2014 Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: ... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Num... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 21, 2014 HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company.... Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prio... Class II Instrumentation Laboratory Co.
Nov 20, 2014 Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg... VCG battery ignited in a VCG unit when recharging. Class II Philips Medical Systems, Inc.
Nov 19, 2014 ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside ... When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor... Class II Philips Electronics North America Corporation
Nov 19, 2014 Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010... Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting Class II ConforMIS, Inc.
Nov 19, 2014 Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliV... Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneou... Class II Philips Medical Systems, Inc.
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitor... Class II Philips Medical Systems, Inc.
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ... MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tid... Class II Philips Medical Systems, Inc.
Nov 19, 2014 HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,... Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadverte... Class II Philips Medical Systems, Inc.
Nov 10, 2014 MEVION S250, used for proton radiation therapy. Software defect that causes an incorrect dose compensation function to be applied to the internal... Class II Mevion Medical Systems, Inc.
Nov 10, 2014 CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device *... An increase in complaint trending for a loss of audible sound associated with the timer has been ... Class II CSA Medical
Oct 27, 2014 Drill set long, drill stop compatible for 4.8mm diameter implant, Article Num... Drill set may contain incorrect drill. Class II Straumann USA, LLC
Oct 21, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile... Class II Gyrus Acmi, Incorporated
Oct 13, 2014 Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot ... Class II Medtronic Vascular
Oct 10, 2014 Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an... Mold on gel filled Gel-E and Squishon products Class I Philips Medical Systems, Inc.
Oct 9, 2014 Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light h... Class II Cynosure, Inc.
Oct 6, 2014 ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... Class III Siemens Healthcare Diagnostics, 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.