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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

983 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 983 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 983 FDA device recalls.

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DateProductReasonClassFirm
Jun 11, 2014 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DAT... Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow ... Class I GE Healthcare, LLC
Jun 4, 2014 GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for us... GE Healthcare has become aware of a potential safety issue due to a collimator installation error... Class II GE Healthcare, LLC
Jun 4, 2014 GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolut... GE Healthcare has become aware of a potential safety issue due to a collimator installation error... Class II GE Healthcare, LLC
May 23, 2014 GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV an... Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the ga... Class II GE Healthcare, LLC
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
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 23, 2014 GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w ... GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products.... Class II GE Healthcare, LLC
Apr 9, 2014 GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: ... When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmi... Class II GE Healthcare, LLC
Apr 7, 2014 GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 ... GE Healthcare has recently become aware of a potential safety issue due to higher than actual flo... Class II GE Healthcare, LLC
Apr 3, 2014 The Centricity PACS Workstation is intended for use as a primary diagnostic a... It has been identified that in a reject image workflow where multiple studies are simultaneously ... Class II GE Healthcare
Apr 2, 2014 GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450... Potential safety issue with gradient coil electromechanical connections associated with GE MR Pro... Class II GE Healthcare, LLC
Apr 2, 2014 Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM pa... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared ... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controll... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Apr 2, 2014 Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrar... Medical device software may be defective and may cause user-set alarm limits to result in false p... Class II GE Healthcare
Mar 31, 2014 The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic ... GE Healthcare has identified a potential safety issue related to the screws that attach the works... Class II GE OEC Medical Systems, Inc
Mar 27, 2014 GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specializ... GE Healthcare has recently become aware of a potential safety issue where the probe power surveil... Class II GE Healthcare, LLC
Feb 28, 2014 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 C... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Feb 14, 2014 GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio... GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc... Class II GE Healthcare, LLC
Feb 13, 2014 GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.... GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patien... Class II GE Healthcare, LLC
Feb 7, 2014 GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Du... Potential safety issue related to unintended radial detector motion, which may occur during patie... Class II GE Healthcare, LLC
Feb 7, 2014 GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended u... Potential safety issue related to unintended radial detector motion, which may occur during patie... Class II GE Healthcare, LLC
Feb 7, 2014 Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... Potential safety issue related to unintended radial detector motion, which may occur during patie... Class II GE Healthcare, LLC
Jan 20, 2014 GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital ... GE Healthcare has recently become aware of a software issue associated with patient selection fro... Class II GE Healthcare, LLC
Dec 27, 2013 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARES... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Dec 20, 2013 CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intende... There is a potential for communication loss associated with the F5-01 Frame when connected to CAR... Class II GE Healthcare, LLC
Dec 16, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... GE Healthcare has recently become aware of a potential safety issue which affects all Patient Da... Class II GE Healthcare, LLC
Dec 12, 2013 Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warme... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthc... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled i... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 20... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M122... Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... Class II GE Healthcare
Dec 12, 2013 GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging sys... GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D,... Class II GE Healthcare, LLC
Dec 11, 2013 GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova... GE Healthcare has become aware of a potential safety issue involving the innova systems. The Inno... Class II GE Healthcare, LLC
Dec 5, 2013 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intende... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Dec 5, 2013 GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: Th... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Dec 5, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Nov 27, 2013 GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM)... GE Healthcare has recently become aware of a potential safety issue due to intermittent failure o... Class II GE Healthcare, LLC
Nov 27, 2013 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port... GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash... Class II GE Healthcare, LLC
Nov 20, 2013 GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery ... GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection... Class II GE Healthcare, LLC
Nov 15, 2013 GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imagi... GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imagi... Class II GE Healthcare, LLC
Nov 8, 2013 Video Monitor Suspensions that may be on the following Fluoroscopic and Radio... Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws t... Class II GE Healthcare, LLC
Nov 7, 2013 GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiograph... There exists a software issue associated with patient selection from the worklist on the Optima X... Class II GE Healthcare, LLC
Oct 25, 2013 GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo ... GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan proce... Class II GE Healthcare, LLC
Oct 11, 2013 HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40,... GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings as... Class II GE Healthcare, LLC
Oct 11, 2013 GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasoun... GE became aware of a potential safety issue due to a system slow down and system lock up associat... Class II GE Healthcare, LLC
Oct 9, 2013 GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Inten... There is an issue with the Manual Film Composer feature on some CT products. There is an opportu... Class II GE Healthcare, LLC
Oct 1, 2013 GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-... Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... Class I GE Healthcare, LLC

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.