Browse Device Recalls
150 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 150 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 150 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 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 |
| Feb 18, 2025 | GE Healthcare Revolution Apex, 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 |
| Jan 28, 2025 | Discovery XR656HD. X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... | Class II | GE Medical Systems, LLC |
| Jan 28, 2025 | Discovery XR656 HD. X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... | 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.