Resmed Ltd.: Ventilator, Continuous, Facility Use
Recall Summary ResMed Astral 100/150 ventilators are being recalled worldwide because a leaking supercapacitor on an internal circuit board may damage the charger chip, potentially causing the ventilator to stop working and interrupt breathing support for patients. The recall affects ventilators distributed across the United States, Canada, Europe, Asia, the Middle East, and other regions. This is a Class II recall, meaning there is a potential for serious adverse health consequences but not an immediate threat of death or serious injury.
- Recalling firm
- ResMed Ltd.
- Product
- 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.
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c6370880-79df-46b6-ba52-efd70b9dde2c