Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 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 474 FDA device recalls.

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DateProductReasonClassFirm
Dec 23, 2019 SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a... It was identified that due to a potential installation workflow issue, the MR system date could b... Class II GE Healthcare, LLC
Dec 23, 2019 SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is... It was identified that due to a potential installation workflow issue, the MR system date could b... Class II GE Healthcare, LLC
Dec 16, 2019 Centricity Universal Viewer 6.0, a device that displays medical images and da... Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are inco... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Dec 3, 2019 Lunar iDXA bone densitometer An issue with the Lunar iDXA control panel may cause the start button to not release and potentia... Class II GE Healthcare, LLC
Nov 25, 2019 Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended... GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... Class I GE Healthcare, LLC
Nov 25, 2019 Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended... GE Healthcare has become aware that there is a potential for a loose cable connection inside spec... Class I GE Healthcare, LLC
Nov 12, 2019 CARESCAPE Central Station - Product Usage: The intended use is to provide cli... When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... Class II GE Healthcare, LLC
Nov 12, 2019 CIC Pro Clinical Information Center Central Station - Product Usage: The inte... When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... Class II GE Healthcare, LLC
Nov 12, 2019 ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is int... When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain v... Class II GE Healthcare, LLC
Oct 11, 2019 Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe Omn... Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe Incubator infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe OmniBed infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Oct 11, 2019 Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestatio... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCOVX Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCAiOE Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCAiOVE Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCAiO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 Airway Gas Option N-CAiO Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 27, 2019 CARESCAPE Respiratory Module E-sCAiOV Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect ... Class I GE Healthcare, LLC
Sep 16, 2019 CardioLab/ComboLab Recording Systems Potential for failure of the patient leakage current test. There is a potential that if another d... Class II GE Healthcare, LLC
Sep 3, 2019 Achilles Insight Bone Sonometer Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow... Class II GE Healthcare, LLC
Sep 3, 2019 Achilles Express Bone Sonometer Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow... Class II GE Healthcare, LLC
Aug 30, 2019 ApexPro Telemetry Server System. Also identified as Modification To: ApexPro... May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Informa... Class II GE Healthcare, LLC
Aug 9, 2019 Proteus XR/a (SlOK : K993090) Intermittently not receiving an audible exposure indication upon completion of an exposure on the... Class II GE Healthcare, LLC
Jul 26, 2019 Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated a... Fasteners potentially torqued to a value less than the specified value and can potentially cause ... Class II GE Healthcare, LLC
Jul 19, 2019 Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3.... Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... Class II GE Healthcare, LLC
Jul 19, 2019 Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-91... Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... Class II GE Healthcare, LLC
Jul 19, 2019 Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023... Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... Class II GE Healthcare, LLC
Jul 19, 2019 Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-... Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... Class II GE Healthcare, LLC
Jul 2, 2019 Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish R... Potential for a transducer mis-alignment in certain transvaginal probes. Class II GE Healthcare, LLC
Jul 2, 2019 Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D Potential for a transducer mis-alignment in certain transvaginal probes. Class II GE Healthcare, LLC
Jun 28, 2019 MAC VU360, Model Number 2030360-001, Electrocardiograph Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit ... Class II GE Healthcare, LLC
May 22, 2019 GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 ... There is a potential that one or more image series (i.e., all images within an image set) may b... Class II GE Healthcare, LLC
May 21, 2019 LVivo EF app on Vscan Extend. Sold under the following product names: a... Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo E... Class II GE Healthcare, LLC
May 17, 2019 Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255... There is a potential that one or more images or image series may be missing from exams without a ... Class II GE Healthcare, LLC
May 17, 2019 Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-00... There is a potential that one or more images or image series may be missing from exams without a ... Class II GE Healthcare, LLC
May 16, 2019 Centricity PACS Foundation Centricity PACS software product is intended fo... There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... Class II GE Healthcare, LLC
May 16, 2019 GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory ... Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. Class II GE Healthcare, LLC
May 16, 2019 GE Senographe Pristina - Product Usage: Senographe Pristina generates digital... Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. Class II GE Healthcare, LLC
May 16, 2019 Centricity Universal Viewer 6.0 Is a device that displays medical images a... There is the possibility of viewing studies directly from the Enterprise Archive or VNA with inco... Class II GE Healthcare, LLC
May 10, 2019 ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire... ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... Class III GE Healthcare, LLC
May 10, 2019 Replacement ECG leadwires with snap ends REF/Catalog Number Description 210... ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... Class III GE Healthcare, LLC
May 10, 2019 ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cab... ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... Class III GE Healthcare, LLC
May 10, 2019 Replacement leadwires with grabber ends: REF/Catalog Number Description 210... ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... Class III GE Healthcare, LLC
May 10, 2019 Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 EC... ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibr... Class III GE Healthcare, LLC
Mar 29, 2019 Precision 500D The Precision 500D R&F X-ray System is intended to be used... There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... 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.