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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
| Aug 13, 2025 | Change Healthcare Radiology Solutions software version 14.2.2 | Due to software issue, radiology reports may not be fully displayed when viewing. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 11, 2025 | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schill... | Class II | Merge Healthcare, Inc. |
| Jul 2, 2025 | GE HealthCare OEC 9800. | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... | Class II | GE Medical Systems, LLC |
| Jul 2, 2025 | GE HealthCare OEC 9900 Elite C-arm Systems. | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, LLC |
| Jun 20, 2025 | GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System | GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... | Class II | GE Medical Systems, 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.