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
Mar 16, 2018	GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU...	Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de...	Class II	GE Medical Systems Ultrasound & Primary Care Di...
Mar 12, 2018	McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological mo...	Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monit...	Class II	McKesson Israel Ltd.
Feb 23, 2018	GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 204958...	A database handling error could occur during the image acquisition process affecting the complete...	Class II	GE Healthcare
Jan 25, 2018	Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW wit...	Potential that one or more image series may be missing from an exam without a user warning disp...	Class II	GE Healthcare
Jan 25, 2018	Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricit...	Potential that one or more image series may be missing from an exam without a user warning disp...	Class II	GE Healthcare
Jan 11, 2018	GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th...	CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (...	Class II	GE Medical Systems Information Technologies, Inc.
Dec 15, 2017	Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Pro...	if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected...	Class II	GE Healthcare, LLC
Dec 15, 2017	Uterine Electromyographic Monitor -Monica IF24 Interface System Product Us...	if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected ...	Class II	GE Healthcare, LLC
Oct 30, 2017	VariCam	A potential hazardous situation may occur if the collimator locking handle is not properly placed...	Class II	GE Healthcare, LLC
Oct 30, 2017	Discover VH/Millennium VG Nuclear Medicine Imaging System	A potential hazardous situation may occur if the collimator locking handle is not properly placed...	Class II	GE Healthcare, LLC
Oct 4, 2017	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered deliv...	Non-Conforming devices were shipped from the service center without proper evaluation and therefo...	Class II	GE Healthcare, LLC
Oct 4, 2017	DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used...	Non-Conforming devices were shipped from the service center without proper evaluation and therefo...	Class II	GE Healthcare, LLC
Aug 14, 2017	Merge Unity software, formerly known as DR Systems Unity PACS software. The ...	The software is not identifying the patient as having atypical hyperplasia, resulting in an incor...	Class II	Merge Healthcare, Inc.
Aug 7, 2017	Merge Unity software, formerly known as DR Systems Unity PACS software. The ...	The software is not identifying the patient as having atypical hyperplasia, resulting in an incor...	Class II	Merge Healthcare, Inc.
Jun 13, 2017	Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo...	When the user has not set up any user preference on the sorting order to render the study images ...	Class II	Merge Healthcare, Inc.
May 24, 2017	Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha...	Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t...	Class II	Merge Healthcare, Inc.
May 24, 2017	Merge OrthoPACS software.	A migrated study that has annotations will display the annotations, but when a prior study is loa...	Class II	Merge Healthcare, Inc.
May 19, 2017	GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX ...	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Revolution EVO X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT660, CT680 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery NM/CT 670 CZT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery Ml X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Lightspeed RT16 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare LightSpeed VCT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery IQ X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT540 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery Ml DR X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Discovery NM/CT 570c X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare BrightSpeed X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare lnnova IGS 540 ACT X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 19, 2017	GE Healthcare Optima CT520 X-ray system	It was discovered that an issue has been identified that can result in a scan starting before the...	Class II	GE Healthcare, LLC
May 15, 2017	Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0...	Potential for electric shock in the case of a failure to install the grommets, supplied with the ...	Class II	Perkinelmer Life Sciences, Inc.
May 8, 2017	Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan...	Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk...	Class II	Merge Healthcare, Inc.
May 8, 2017	Merge PACS software. Merge PACS (Picture Archiving Communication System) is...	When cut lines are shown on an image, the lines may go from being vertical and then shift to hori...	Class II	Merge Healthcare, Inc.
May 5, 2017	Infant Warmer System (IWS)	GE Healthcare has recently become aware of a potential safety issue related to loose screws in t...	Class II	GE Healthcare, LLC
May 2, 2017	Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1	Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction	Class II	GE Healthcare, LLC
Apr 6, 2017	Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power s...	Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLi...	Class II	Merge Healthcare, Inc.
Mar 10, 2017	Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.	GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly...	Class II	GE Healthcare, LLC
Mar 10, 2017	Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.	GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly...	Class II	GE Healthcare, LLC
Feb 6, 2017	Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems	Reported incidents of a patient step detaching from the table. A fall from a patient step detach...	Class II	GE Healthcare, LLC
Jan 23, 2017	Merge LIS	A defect in the software resulted in medications that are not associated with the patient (i.e., ...	Class II	Merge Healthcare, Inc.
Jan 20, 2017	Discovery MR450 The systems are whole body magnetic resonance scanners des...	Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI....	Class II	GE Healthcare, LLC
Dec 27, 2016	OEC 9800. MDL Numbers: D222250, D141598	GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ...	Class II	GE OEC Medical Systems, Inc
Dec 27, 2016	OEC 9900 Elite. MDL Numbers: D148942, D155043	GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due ...	Class II	GE OEC Medical Systems, Inc
Dec 19, 2016	The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluorosco...	GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit...	Class II	GE OEC Medical Systems, Inc
Dec 19, 2016	OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile ...	GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit...	Class II	GE OEC Medical Systems, Inc
Dec 19, 2016	OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide ...	GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elit...	Class II	GE OEC Medical Systems, Inc
Dec 9, 2016	Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStat...	This recall has been initiated due to an issue related to the potential accidental deletion of re...	Class II	Merge Healthcare, 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.