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 |
|---|---|---|---|---|
| Jul 22, 2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | Class II | Merge Healthcare, Inc. |
| Jul 10, 2026 | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitor... | A software vulnerability may allow unauthorized persons to gain privileged access to the device, ... | Class II | GE Medical Systems Information Technologies Inc |
| Jun 30, 2026 | Merge OrthoPACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Merge PACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 29, 2026 | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an ... | Class II | GE Medical Systems Information Technologies Inc |
| Jun 5, 2026 | Optima XR240amx, Mobile Digital Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Jun 5, 2026 | Optima XR220amx, Mobile Digital-Ready Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| Jun 5, 2026 | Optima XR200amx, Mobile Digital-Ready Radiographic System | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... | Class II | GE Medical Systems, LLC |
| May 8, 2026 | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When... | Class II | GE Medical Systems SCS |
| May 1, 2026 | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combinati... | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... | Class II | GE Medical Systems, LLC |
| May 1, 2026 | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, A... | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... | Class II | GE Medical Systems, LLC |
| May 1, 2026 | Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and... | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... | Class II | GE Medical Systems, LLC |
| Apr 24, 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Prod... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, ... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, ... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 20, 2026 | Allia IGS 7 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia IGS 5 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia Moveo angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia IGS Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Apr 20, 2026 | Allia IGS 3 Pulse angiographic X-ray system | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000... | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Mar 26, 2026 | Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 | GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed... | Class II | GE Medical Systems, LLC |
| Feb 27, 2026 | SIGNA Premier systems | Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of... | Class II | GE Healthcare LLC |
| 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 |
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.