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Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 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 922 FDA device recalls in WI.

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DateProductReasonClassFirm
Oct 8, 2014 Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . ... The recall has been initiated due to concerns that the applicator wand may malfunction potentiall... Class II Ad-Tech Medical Instrument Corporation
Oct 7, 2014 Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: Th... Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Sur... Class II Mortara Instrument, Inc
Sep 29, 2014 Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system ... It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update... Class II Merge Healthcare, Inc.
Sep 19, 2014 GE Healthcare Carescape Patient Data Module GE Healthcare has recently become aware of a potential safety issue to the ECG calculations foll... Class II GE Healthcare, LLC
Sep 5, 2014 GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Pr... GE Healthcare has become aware of a potential safety issue involving missing screws used for moun... Class II GE Healthcare, LLC
Sep 4, 2014 Innova 4100IQ Indicated for use in generating fluoroscopic images of human... Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... Class II GE Healthcare, LLC
Sep 4, 2014 Discovery IGS 740 Indicated for use for patients from newborn to geriatric... Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... Class II GE Healthcare, LLC
Sep 4, 2014 Innova IGS 540 Indicated for use for patients from newborn to geriatric in... Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/... Class II GE Healthcare, LLC
Aug 28, 2014 eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components ... There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studie... Class II Merge Healthcare, Inc.
Aug 8, 2014 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-s... GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sen... Class II GE Healthcare, LLC
Jul 25, 2014 GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate dig... GE Healthcare has become aware of a potential safety issue involving the nylon hooks which suppor... Class II GE Healthcare, LLC
Jul 21, 2014 Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS98... The bed head deck may fail to elevate as expected during normal operation. When the non-operatio... Class II GF Health Products, Inc./d.b.a.Basic American M...
Jul 17, 2014 TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (H... Class II TomoTherapy Incorporated
Jul 16, 2014 TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003... Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ ... Class II TomoTherapy Incorporated
Jul 7, 2014 GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor inte... Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is conn... Class II GE Healthcare, LLC
Jun 13, 2014 GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PD... Class II GE Healthcare, LLC
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 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
Mar 27, 2014 INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version... An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrat... Class II INO Therapeutics (dba Ikaria)
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 24, 2014 AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Sprin... The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a m... Class II Allesee Orthodontic Appliances
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 11, 2014 Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Philips Medical Systems have recently determined that a software nonconformance can cause incorre... Class II Philips Medical Systems (Cleveland), Inc.
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 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

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.