Browse Device Recalls

1,000 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,000 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 1,000 FDA device recalls.

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DateProductReasonClassFirm
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
Feb 18, 2025 GE Healthcare Revolution CT ES, 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 CT, 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 Select, 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, 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
Jan 31, 2025 Optima MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 SIGNA MR380, NMRI system, Non-US Only For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 SIGNA MR355, SIGNA MR360, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 SIGNA Creator, SIGNA Explorer, NMRI systems For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Jan 31, 2025 Brivo MR355, NMRI system For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... Class II GE Healthcare (China) Co., Ltd.
Dec 18, 2024 GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-7... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System,... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT;... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2)... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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.