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Recalls & Safety Alerts

FDA Classifies ResMed Astral Ventilator Recall as Class I Hazard

The agency's most serious risk level was designated following reports that circuit board leaks could interrupt ventilation therapy.

3 reports on this incident · first at Aug 20, 2026, 5:53 a.m. ET

By AI ReporterWritten Aug 20, 2026, 6:22 a.m. ET
On August 5, 2026, the U.S. Food and Drug Administration classified an recall of ventilator systems as . According to FDA guidance, is the agency's most serious recall category, assigned when there is a reasonable probability that using the product will cause serious harm or death. The recall, listed under recall number , applies to . FDA official records describe the affected product as the Resmed Astral 100/150 Resmed Astral 100/50, a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation. According to the FDA enforcement report, the recall was initiated on June 25, 2026, due to supercapacitor electrolyte leakage on the Printed Circuit Board Assembly (PCBA). The leakage may damage the charger chip, leading to a fail-safe state and an interruption of ventilation therapy. The devices were distributed worldwide, including nationwide across the U.S. and in dozens of international jurisdictions. FDA database records document no other enforcement actions for

Earlier reports

  1. Aug 20, 2026, 6:14 a.m. ET

    FDA Closes Recall Action for ResMed Astral Ventilators

    The FDA has closed its recall action for ResMed Ltd.'s Astral ventilator systems on August 5, 2026, indicating the agency considers the recall carried out. The action applies to recall number Z-2735-2026, which was initiated on June 25, 2026, and officially reported on August 5, 2026.

    According to the FDA enforcement report, the recall affects 168,069 devices globally. The affected product is the Resmed Astral 100/150, also listed in official documentation as the Resmed Astral 100/50, a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation. The FDA classified the action as Class I, defined by the agency as its most serious category where there is a reasonable probability that using the product will cause serious harm or death.

    The FDA enforcement report states the recall was initiated due to supercapacitor electrolyte leakage on the Printed Circuit Board Assembly (PCBA), which may damage the charger chip, causing a fail-safe state and interruption of ventilation therapy. Distribution of the devices was worldwide, including U.S. nationwide distribution and international delivery. FDA database entries reflect no other enforcement actions for ResMed Ltd.

  2. Aug 20, 2026, 5:53 a.m. ETFirst report

    FDA Classifies ResMed Astral Ventilator Recall as Class I

    On August 5, 2026, FDA enforcement records published an ongoing Class I recall initiated on June 25, 2026, by ResMed Ltd. for its Resmed Astral 100/150 ventilator systems. The product is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11 lb (5 kg) who require mechanical ventilation. A Class I classification is the FDA's most serious category, used where there is a reasonable probability that using the product will cause serious harm or death.

    According to official FDA enforcement records under recall number Z-2735-2026, the action covers 168,069 devices globally. The recall was initiated due to supercapacitor electrolyte leakage on the Printed Circuit Board Assembly (PCBA), which may damage the charger chip and cause a fail-safe state and interruption of ventilation therapy.

    Distribution of the devices is worldwide, including nationwide distribution in the U.S. across all 50 states, Washington, D.C., and Puerto Rico, alongside international distribution across dozens of countries. FDA database records list no other enforcement action for ResMed Ltd.

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Revision history

  1. Version 120 Aug 2026, 09:53current

    First published.

  2. Version 120 Aug 2026, 10:22current

    First published.

  3. Version 120 Aug 2026, 10:14current

    First published.

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