Browse Device Recalls
2,817 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,817 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 2,817 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 16, 2025 | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), sof... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmente... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radio... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 15, 2025 | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566... | It was found that the shaft for mounting the X-ray tube unit on the support may break. In additio... | Class II | FUJIFILM Healthcare Americas Corporation |
| Sep 15, 2025 | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: ... | XXX | Class II | Alcon Research LLC |
| 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 | Cardiac Workstation 7000; Model Number: 860441; | Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... | Class II | Philips North America |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| 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 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| 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 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| 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 | Product: STA Liatest D-Di; REF: 00515; | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. | Class II | Diagnostica Stago, Inc. |
| 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 | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 0088633321... | Due to complaints of increased resistance when advancing the dilator within the introducer sheath... | Class II | Argon Medical Devices, Inc |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| 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 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| 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 | Cardiac Workstation 5000; Model Number: 860439; | Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... | Class II | Philips North America |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number:... | Due to Users not having access to the Instructions for Use/User Manual due to it being password p... | Class II | Noah Medical Corporation |
| 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 12, 2025 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that di... | Class II | Medtronic Perfusion Systems |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (1... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (1... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | The failure occurs if a user on the Omnipod 5 iOS application selects and hol... | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual ... | Class II | Insulet Corporation |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
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.