Signals
Regulatory notices, standards drafts, advisories and device recalls that matter to healthcare security, refreshed every six hours from the publishing agencies. Breach reports have their own register.
| Published | Source | Title | Tags |
|---|---|---|---|
| Oct 24, 2025 | FDA device recall | Surgical Theater Inc: System, Image Processing, Radiological | FDA recall, medical device, class 2, Radiology |
| Oct 23, 2025 | FDA device recall | Tandem Diabetes Care, Inc.: Alternate Controller Enabled Insulin Infusion Pump | FDA recall, medical device, class 2, Clinical Chemistry |
| Oct 21, 2025 | FDA device recall | Beckman Coulter, Inc.: Radioimmunoassay, Thyroid-Stimulating Hormone | FDA recall, medical device, class 2, Clinical Chemistry |
| Oct 21, 2025 | FDA device recall | Beckman Coulter, Inc.: Radioimmunoassay, Cortisol | FDA recall, medical device, class 2, Clinical Chemistry |
| Oct 21, 2025 | FDA device recall | Wipro GE Healthcare Private Ltd.: Display, Cathode-Ray Tube, Medical | FDA recall, medical device, class 2, Cardiovascular |
| Oct 21, 2025 | FDA device recall | Wipro GE Healthcare Private Ltd.: Display, Cathode-Ray Tube, Medical | FDA recall, medical device, class 2, Cardiovascular |
| Oct 14, 2025 | FDA device recall | Kico Knee Innovation Company: Orthopedic Augmented Reality | FDA recall, medical device, class 2, Neurology |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Cardioverter Defibrillator (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 10, 2025 | FDA device recall | Boston Scientific Corporation: Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA recall, medical device, class 3, Unknown |
| Oct 9, 2025 | FDA device recall | Abiomed, Inc.: Temporary Non-Roller Type Left Heart Support Blood Pump | FDA recall, medical device, class 3, Unknown |
| Oct 8, 2025 | FDA device recall | GE Medical Systems, SCS: System, Image Processing, Radiological | FDA recall, medical device, class 2, Radiology |
| Oct 8, 2025 | FDA device recall | Canon Medical System, USA, INC.: Interventional Fluoroscopic X-Ray System | FDA recall, medical device, class 2, Radiology |
| Oct 2, 2025 | FDA device recall | CHANGE HEALTHCARE CANADA COMPANY: System, Image Processing, Radiological | FDA recall, medical device, class 2, Radiology |
| Sep 29, 2025 | Federal Register | Determination of Regulatory Review Period for Purposes of Patent Extension; NIKTIMVO | information blocking, Notice, Health and Human Services Department, Food and Drug Administration |
| Sep 26, 2025 | FDA device recall | Zap Surgical Systems: Accelerator, Linear, Medical | FDA recall, medical device, class 2, Radiology |
| Sep 26, 2025 | FDA device recall | Bard Peripheral Vascular Inc: Electrosurgical, Cutting & Coagulation & Accessories | FDA recall, medical device, class 2, General, Plastic Surgery |
| Sep 24, 2025 | Federal Register | Agency Information Collection Activities: Submission for OMB Review; Comment Request | HIPAA, Notice, Health and Human Services Department, Centers for Medicare & Medicaid Services |
| Sep 23, 2025 | Federal Register | Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity | information blocking, Notice, Health and Human Services Department, Substance Abuse and Mental Health Services Administration |
| Sep 19, 2025 | Federal Register | Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur | information blocking, Rule, Health and Human Services Department, Food and Drug Administration |
| Sep 18, 2025 | Federal Register | Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices | cybersecurity, Rule, Health and Human Services Department, Food and Drug Administration |
| Sep 11, 2025 | Federal Register | Agency Information Collection Request; 60-Day Public Comment Request | HIPAA, Notice, Health and Human Services Department, cybersecurity |
| Aug 29, 2025 | Federal Register | Proposed Information Collection Activity; Office of Community Services Community Economic Development Performance Progress Report | information blocking, Notice, Health and Human Services Department, Children and Families Administration |
| Aug 29, 2025 | Federal Register | Agency Information Collection Activities: Proposed Collection; Comment Request | HIPAA, Notice, Health and Human Services Department, Centers for Medicare & Medicaid Services |
| Aug 27, 2025 | Federal Register | Fiscal Year (FY) 2025 Notice of Supplemental Funding Opportunity | information blocking, Notice, Health and Human Services Department, Substance Abuse and Mental Health Services Administration |
| Aug 26, 2025 | Federal Register | Agency Information Collection Request. 30-Day Public Comment Request | information blocking, Notice, Health and Human Services Department |