Browse Device Recalls
966 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 966 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 966 FDA device recalls in WI.
| 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 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570... | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies 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 16, 2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... | Class II | Accuray Incorporated |
| Jun 16, 2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... | Class II | Accuray Incorporated |
| 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 27, 2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 50460... | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorr... | Class II | Inter-Med Llc |
| May 8, 2026 | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 8, 2026 | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| May 8, 2026 | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator... | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system ca... | Class I | Datex-Ohmeda Inc |
| 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 | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer b... | Class II | GE Medical Systems Information Technologies Inc |
| 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 |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm,... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-2... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Feb 3, 2026 | Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (... | There is a potential issue that can lead to discordance between the simulated needle trajectory/t... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a dev... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Oct 24, 2025 | Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening ... | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which... | Class II | GE Medical Systems, LLC |
| Sep 18, 2025 | LOGIQ P10 series with software version R4.5.7 Model Number 5877534 | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... | 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.