Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

41 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 41 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 41 FDA device recalls.

Clear
DateProductReasonClassFirm
Dec 24, 2025 GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16,... There is a potential intermittent issue on certain Omni Legend systems that can result in a strea... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025 MAXXUS, System, Tomography, Computed, Emission 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
Dec 10, 2025 SMV DSX New Line, System, Tomography, Computed, Emission 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
Dec 10, 2025 SMV BodyTrack, System, Tomography, Computed, Emission 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
Dec 10, 2025 SMV DSI, System, Tomography, Computed, Emission 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 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
Jun 20, 2025 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025 Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-7... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System,... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT;... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2)... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, ... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 18, 2024 GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H24... GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 63... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Apr 15, 2024 MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H39... There is a potential issue regarding the service handles for the internal lead (Pb) covers in tha... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 D... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / D... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ G... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 /... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 19, 2022 GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8... A mitigation may not be correctly implemented. If this is the case, the detector can fall, leadin... Class I GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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.