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
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 11, 2019 Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order and images may not s... Class II Merge Healthcare, Inc.
Jul 11, 2019 Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order and images may not s... Class II Merge Healthcare, Inc.
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
Mar 29, 2019 Proteus XR/a The Proteus XR/a radiographic system offers the flexibility ... There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... Class II GE Healthcare, LLC
Mar 29, 2019 Silhouette VR This fully integrated system offers intuitive controls with... There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... Class II GE Healthcare, LLC
Mar 29, 2019 Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purp... There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... Class II GE Healthcare, LLC
Mar 29, 2019 Prestilix 1600X Prestilix system is a fully integrated remote controlled... There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall m... Class II GE Healthcare, LLC
Mar 25, 2019 Horizon Cardiology Hemo users are not notified of procedure medication discrepancies between the Vitals and Meds, the Pro... Class II Change Healthcare Israel Ltd.
Mar 25, 2019 McKesson Cardiology Hemo users are not notified of procedure medication discrepancies between the Vitals and Meds, the Pro... Class II Change Healthcare Israel Ltd.
Mar 20, 2019 Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose du... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The ... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general ... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for gene... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detecto... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intende... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system i... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medica... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 20, 2019 NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Disco... During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some... Class II GE Healthcare, LLC
Mar 19, 2019 AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, ... The outer seam of the coil, closest to the system cable, may separate and expose the porous mater... Class II GE Healthcare, LLC
Mar 15, 2019 Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating f... There is a potential for loss of the x-ray imaging function when the user changes field of view (... Class II GE Healthcare, LLC
Mar 15, 2019 Innova IGS 630, Angiographic X-Ray, s5i system option used in generating flu... There is a potential for loss of the x-ray imaging function when the user changes field of view (... Class II GE Healthcare, LLC
Mar 15, 2019 Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat... The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack o... Class I GE Healthcare, LLC
Mar 15, 2019 Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat i... The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack o... Class I GE Healthcare, LLC
Mar 15, 2019 Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating flu... There is a potential for loss of the x-ray imaging function when the user changes field of view (... Class II GE Healthcare, LLC
Feb 22, 2019 Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ... The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduc... Class III GE Healthcare, LLC
Feb 12, 2019 Discovery IQ Product Usage: The systems are intended for head and whole b... GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class II GE Healthcare, LLC
Feb 12, 2019 Discovery PET/CT 710 Product Usage: The systems are intended for head and... GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class II GE Healthcare, LLC
Feb 12, 2019 Optima PET/CT 560, 560FX Product Usage: The systems are intended for head... GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class II GE Healthcare, LLC
Feb 12, 2019 Discovery PET/CT 610 Product Usage: The systems are intended for head and... GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class II GE Healthcare, LLC
Feb 12, 2019 Discovery Ml Product Usage: The systems are intended for head and whole ... GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure Class II GE Healthcare, LLC
Feb 12, 2019 Discovery Ml DR Product Usage: The systems are intended for head and whol... GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure 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.