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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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Browse Device Recalls

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Apr 14, 2015 Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... Class II Philips Electronics North America Corporation
Apr 14, 2015 Philips Healthcare Ingenuity Core Computed Tomography X-ray system During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) sc... Class II Philips Electronics North America Corporation
Mar 25, 2015 CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device M... TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may caus... Class II CSA Medical
Mar 23, 2015 Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems w... The system is designed to emit a beep upon termination of an exposure. However, if the system has... Class II Philips Electronics North America Corporation
Mar 5, 2015 CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the C... Needle is leaking from hub/needle cannula connection Class II Codman & Shurtleff, Inc.
Mar 5, 2015 SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique... The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used... Class II SpineFrontier, Inc.
Feb 24, 2015 LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste... Mislabeled with an incorrect expiration date Class III LeMaitre Vascular, Inc.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WIT... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008T with the following product code and ... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008K2 with the following product code and... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 20, 2015 2008 Series Hemodialysis Machines: 2008K with the following product code and ... The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displa... Class II Fresenius Medical Care Holdings, Inc.
Feb 17, 2015 EOS, Digital radiography system used in general radiographic examinations. When performing calibration, an alert message on the spectral filtration of the X-ray beam may be... Class II Eos Imaging Inc
Feb 9, 2015 Philips Healthcare DuraDiagnost X- Ray The system is designed to emit a beep upon termination of an exposure. However, if the system ha... Class II Philips Medical Systems, Inc.
Feb 9, 2015 Philips Healthcare DigitalDiagnost System X-Ray The system is designed to emit a beep upon termination of an exposure. However, if the system ha... Class II Philips Medical Systems, Inc.
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.

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.