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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Dec 18, 2024 | GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; ... | 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, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, ... | 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 Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H24... | 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 2, 2024 | Change Healthcare Cardiology Hemodynamics software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Dec 2, 2024 | Change Healthcare Cardiology Hemo software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Nov 25, 2024 | GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numb... | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Nov 25, 2024 | GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numb... | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Nov 25, 2024 | GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numb... | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography s... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed t... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tom... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/comput... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., 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.