Browse Device Recalls

1,006 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,006 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 1,006 FDA device recalls.

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DateProductReasonClassFirm
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
Sep 26, 2025 Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (Wit... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 26, 2025 CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batt... Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... Class II GE Healthcare Finland Oy
Sep 12, 2025 Optima NX; dual-head nuclear medicine gamma camera designed specifically for ... 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
Sep 12, 2025 Maxicam; dual-head nuclear medicine gamma camera designed specifically for ca... 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
Sep 12, 2025 Elscint Cardial; dual-head nuclear medicine gamma camera designed specificall... 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
Sep 12, 2025 Millenium MPS; dual-head nuclear medicine gamma camera designed specifically ... 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
Sep 12, 2025 Elscint Varicam; dual-head nuclear medicine gamma camera designed specificall... 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
Sep 12, 2025 Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically f... 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
Sep 12, 2025 Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear med... 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
Sep 12, 2025 Elscint Helix; dual-head nuclear medicine gamma camera designed specifically ... 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
Sep 12, 2025 Starcam/Camstar; dual-head nuclear medicine gamma camera designed specificall... 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
Sep 12, 2025 Millenium Myosight; dual-head nuclear medicine gamma camera designed specific... 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
Sep 12, 2025 Millenium MG/MC; dual-head nuclear medicine gamma camera designed specificall... 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
Sep 12, 2025 Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifica... 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
Sep 12, 2025 Millenium MPR; dual-head nuclear medicine gamma camera designed specifically ... 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
Sep 12, 2025 Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically f... 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
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.
Sep 5, 2025 GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with softwar... GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software v... Class II Wipro GE Healthcare Private Ltd.
Aug 13, 2025 Change Healthcare Radiology Solutions software version 14.2.2 Due to software issue, radiology reports may not be fully displayed when viewing. Class II CHANGE HEALTHCARE CANADA COMPANY
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

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.