Browse Device Recalls

969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 969 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 969 FDA device recalls.

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Date	Product	Reason	Class	Firm
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
Oct 1, 2013	GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: T...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Oct 1, 2013	GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe S...	Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d...	Class I	GE Healthcare, LLC
Sep 19, 2013	AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESH...	GE Healthcare has recently become aware of a potential safety issue due to the image orientation ...	Class II	GE Healthcare, LLC
Sep 19, 2013	Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Dispos...	GE Healthcare has recently become aware of a potential safety issue due to air leakage associated...	Class I	GE Healthcare, LLC
Sep 18, 2013	GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus...	GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires ...	Class II	GE Healthcare Beijing , Hangwei Medical Systems...
Sep 16, 2013	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume ...	GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance ...	Class I	GE Healthcare, LLC
Aug 30, 2013	GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is inte...	GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device...	Class II	GE Healthcare, LLC
Aug 28, 2013	GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte...	GE Healthcare has recently become aware of a potential safety issue involving unresponsive button...	Class I	GE Healthcare, LLC
Aug 26, 2013	Merge Mammo is a multi-modality, vendor-neutral digital mammography workstati...	There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo vie...	Class II	GE Healthcare It
Aug 16, 2013	GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100I...	GE Healthcare has become aware of a potential safety issue involving missing screws in the overhe...	Class II	GE Healthcare, LLC
Aug 13, 2013	GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 ...	GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on...	Class II	GE Healthcare, LLC
Aug 7, 2013	GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be u...	GE has recently become aware of a potential safety issue due to the incorrect calculation of the ...	Class II	GE Healthcare, LLC
Jul 29, 2013	Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The D...	GE Healthcare has recently become aware of a potential safety issue involving the pre-operative c...	Class II	GE Healthcare, LLC
Jul 18, 2013	Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 un...	GE Healthcare has become aware of a potential safety issue associated with the use of GE General ...	Class II	Vital Signs Devices, a GE Healthcare Company

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.