Browse Device Recalls

918 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 918 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 918 FDA device recalls in WI.

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DateProductReasonClassFirm
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
Sep 18, 2025 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model N... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 18, 2025 LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Mod... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Aug 22, 2025 MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multic... If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can re... Class II GE Medical Systems, LLC
Aug 11, 2025 Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schill... Class II Merge Healthcare, Inc.
Jul 2, 2025 GE HealthCare OEC 9800. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... Class II GE Medical Systems, LLC
Jul 2, 2025 GE HealthCare OEC 9900 Elite C-arm Systems. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography wi... GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Signa Voyager, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Signa Artist, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
May 23, 2025 Discovery MR750w 3.0T GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 SIGNA PET/MR GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 SIGNA Architect AIR GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
May 23, 2025 SIGNA Architect GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... Class II GE Medical Systems, LLC
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 OEC 3D OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. Class II GE Medical Systems, LLC
Mar 21, 2025 OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and... OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. Class II GE Medical Systems, LLC
Mar 6, 2025 Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number ... The battery for certain ultrasound systems can potentially develop an internal failure which coul... Class II GE Medical Systems, LLC
Mar 6, 2025 Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (... The battery for certain ultrasound systems can potentially develop an internal failure which coul... Class II GE Medical Systems, LLC
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 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 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

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.