Browse Device Recalls

168 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 168 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 168 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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
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
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

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.