Home / Recalls / Medical Devices
ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilator
Recalled August 5, 2026 · FDA recall Z-2735-2026 · ResMed
Hazard
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. · FDA Class I
Units
168,069 devices globally
Sold at
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, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Martin (French part), Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Viet Nam.
Description
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.
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.
Manufacturer(s)
ResMed Ltd.
Made in
Australia
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →