ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides cont…

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

ResMed Urgent Medical Device Correction Astral 100/150 Ventilators Issue Identified: On June 25, 2026, ResMed notified customers via Salesforce of an urgent medical device correction involving a subset of Astral 100 and Astral 150 ventilators. An internal supercapacitor may leak electrolyte over time, potentially damaging the printed circuit board assembly (PCBA) and causing the ventilator to enter a fail-safe state. Interim Guidance: Due to limited PCBA replacement availability, immediate correction of all affected units is not feasible. Physicians and patients are advised to follow Astral 100/150 User and Clinical Guides, including recommendations on monitoring, emergency preparedness, caregiver training, and backup ventilation. Required Actions for Healthcare Providers and Distributors: Acknowledge: Complete and return the acknowledgment form by July 31, 2026. Notify: Distribute the correction notice and accompanying letters to all relevant healthcare professionals, patients, and caregivers immediately. Reinforce Safety Measures: Ensure ventilator-dependent patients are monitored, caregivers are trained in alarm response and emergency procedures, and backup ventilation equipment is functional and readily available. Device Management: Do not remove an affected ventilator from use unless an alternative is immediately available. Replace inoperable units promptly; patients should continue therapy unless directed otherwise by their clinician. Risk Assessment: Evaluate affected patients by clinical risk category (Tier 1, 2, or 3) per Appendix A. Arrange Inspection: Schedule ventilator inspections per the Phase 1 Inspection and Correction Strategy in Appendix A, returning units to an authorized service center as needed. Contact: Reach your local ResMed representative or visit www.resmed.com/contact for questions.

• FDA enforcement recordOfficial FDA database entry for Z-2735-2026
• FDA 510(k) clearance · K152068The device's official FDA premarket clearance record
• FDA 510(k) clearance · K172875The device's official FDA premarket clearance record
• FDA device classification · CBKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5895The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ResMed Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.