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.

Clear
DateProductReasonClassFirm
Apr 24, 2026 GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Prod... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, ... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, ... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Mar 26, 2026 Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Mar 26, 2026 Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Mar 26, 2026 Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Mar 26, 2026 Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Mar 26, 2026 Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Mar 26, 2026 Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000... GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Mar 26, 2026 Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... Class II GE Medical Systems, LLC
Feb 27, 2026 SIGNA Premier systems Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of... Class II GE Healthcare LLC
Jan 16, 2026 GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Number... Under certain workflows, patient information shown in the viewer may not match the images display... Class II GE Healthcare
Dec 24, 2025 GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16,... There is a potential intermittent issue on certain Omni Legend systems that can result in a strea... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 MAXXUS, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 SMV DSX New Line, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 SMV BodyTrack, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 SMV DSI, System, Tomography, Computed, Emission GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Nov 14, 2025 GE Healthcare Carestation anesthesia system Power Management Board (PMB) Fiel... Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... Class I GE Medical Systems China Co., Ltd.
Nov 14, 2025 GE Healthcare Carestation anesthesia system, product number and REF numbers: ... Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... Class I GE Medical Systems China Co., Ltd.
Nov 14, 2025 GE Healthcare Carestation anesthesia system, product number and REF numbers: ... Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... Class I GE Medical Systems China Co., Ltd.
Nov 3, 2025 GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image proces... GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.... Class II GE Healthcare GmbH
Oct 9, 2025 bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imagin... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; Sys... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Sep 26, 2025 Carescape B450, Model no. 5805686 - shipped with potentially affected batteri... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 61... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monito... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (Wit... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batt... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 12, 2025 Optima NX; dual-head nuclear medicine gamma camera designed specifically for ... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Maxicam; dual-head nuclear medicine gamma camera designed specifically for ca... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Elscint Cardial; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Millenium MPS; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Elscint Varicam; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically f... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear med... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Elscint Helix; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Starcam/Camstar; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Millenium Myosight; dual-head nuclear medicine gamma camera designed specific... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Millenium MG/MC; dual-head nuclear medicine gamma camera designed specificall... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifica... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Millenium MPR; dual-head nuclear medicine gamma camera designed specifically ... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 12, 2025 Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically f... GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.

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.