- Recalling firm
- ResMed Ltd.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Catalog 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
- Units affected
- 168,069 devices globally
- Distribution pattern
- 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.
- Firm location
- Bella Vista, N/A, Australia
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2735-2026
- Recall initiated
- June 25, 2026
- FDA classification date
- July 28, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99304
- Last updated on HTM Vibe
- August 11, 2026