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Recall archive / FDA device enforcement

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilator... — FDA record Z-2735-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 25, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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 I
Recalling firm
ResMed Ltd.
Quantity
168,069 devices globally
Agency-reported status
Ongoing
Source record identifier
Z-2735-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityCatalog Number: Astral 100 UDI-DI code: 00619498003259 Serial Numbers: Astral Ventilators-Serial number < 22241890149 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070 Catalog Number: Astral 150 UDI-DI code: 00619498270033 Serial Numbers: Astral Ventilator-Serial numbers < 22241440282 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070

Match all identifying details in the current notice. A brand name alone is not enough.

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, 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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Aug 5, 2026
Recall initiation date
Jun 25, 2026
Center classification date
Jul 28, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsResMed Ltd. records