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 |
|---|---|---|---|---|
| Jun 20, 2025 | GE SIGNA PET/MR AIR Plus (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 Voyager 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 Elite (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 PET/MR, Tomographic Imager Combining Emission Computed Tomography wi... | 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 PET/MR 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 Artist Evo, 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 XT (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 Discovery MR450 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 Discovery MR750 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 Voyager, 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 XT (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 Premier Elite (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 Artist, 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 |
| May 23, 2025 | Discovery MR750w 3.0T | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | SIGNA PET/MR | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | SIGNA Architect AIR | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | SIGNA Architect | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 22, 2025 | Change Healthcare Cardiology Hemo Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| May 22, 2025 | Change Healthcare Cardiology Hemodynamics Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| May 16, 2025 | GE Healthcare Versana Ultrasound Systems, sold under the following names and ... | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... | Class II | GE Medical Systems China Co., Ltd. |
| May 16, 2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, dia... | GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on ... | Class II | GE Medical Systems China Co., Ltd. |
| Apr 25, 2025 | MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large ca... | The MUSE Administrator Account active directory or local credential could potentially be used fro... | Class II | GE Medical Systems Information Technologies Inc |
| Mar 21, 2025 | GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 202229... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001;... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, Inc. |
| Feb 19, 2025 | GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numb... | There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-... | Class II | GE Healthcare |
| Feb 18, 2025 | GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, LLC |
| Feb 18, 2025 | GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | Class II | GE Medical Systems, LLC |
| Feb 18, 2025 | GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed | GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex ... | 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.