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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA... | 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 Select, Model Number, 6670000-55; X-ray/comp... | 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 Advance, Model number 5849504; 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 Frontier, Model Numbers: 1) 5232085-213, 2) 5873009... | 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 Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... | 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 Eagle, Model Number 5849504-3, 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 Optima 680 Expert, Model number 6670000; X-ray/computed tomogra... | 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 ACE, Model number 6670000-3; X-ray/computed tomogra... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Oct 24, 2024 | GE Proteus XR/A radiographic system | Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have no... | Class II | GE Healthcare (China) Co., Ltd. |
| Oct 3, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1... | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... | Class II | GE Healthcare |
| Sep 3, 2024 | GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo n... | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... | Class I | DATEX--OHMEDA, INC. |
| Sep 3, 2024 | GE Heathcare Giraffe OmniBed; neo natal incubator | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation d... | Class I | DATEX--OHMEDA, INC. |
| Aug 29, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalo... | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... | Class II | GE Healthcare |
| Aug 21, 2024 | McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 21, 2024 | Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2... | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 21, 2024 | Horizon Cardiology Hemo. Version 12.2. | A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data e... | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 9, 2024 | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant war... | GE HealthCare has become aware that complete electrical safety testing was not conducted during m... | Class II | Wipro GE Healthcare Private Ltd. |
| Aug 9, 2024 | GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1... | GE HealthCare has become aware that complete electrical safety testing was not conducted during m... | Class II | Wipro GE Healthcare Private Ltd. |
| Aug 8, 2024 | ViewPoint; system, imaging processing, radiological | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... | Class II | GE Healthcare GmbH |
| Aug 8, 2024 | ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591... | The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... | Class II | GE Healthcare GmbH |
| Aug 5, 2024 | GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging proces... | GE HealthCare has become aware of an issue where image storage is not possible when Centricity PA... | Class II | GE Healthcare |
| Jul 23, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbe... | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not sho... | Class II | GE Healthcare |
| Jul 12, 2024 | GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: ... | The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for ... | Class II | GE Healthcare (China) Co., Ltd. |
| Jun 14, 2024 | Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Reson... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | Class II | GE Medical Systems, LLC |
| Jun 14, 2024 | Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic R... | GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... | 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.