Recall Z-2735-2026 ยท CBK Ventilator, Continuous, Facility Use
ResMed Ltd.
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
| Date | Jul 28, 2026 (initiated Jun 25, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 168,069 devices globally |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Ar |
| FDA record | Open on fda.gov |