The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2735-2026·Announced 2026-08-05

ResMed Astral 100/150 Ventilators Recalled Due to Electrolyte Leakage Risk

ResMed is recalling Astral 100/150 ventilators because supercapacitor electrolyte leakage can damage the charger chip, trigger a fail-safe state, and interrupt ventilation therapy.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which under the rubric corresponds to a reasonable probability of serious adverse health consequences or death. Therefore the severity score is 5 (Critical).

Plain-English summary

ResMed is recalling its Astral 100 and Astral 150 ventilators, which provide continuous or intermittent ventilatory support for patients weighing more than 11 lb (5 kg) who require mechanical ventilation. The recall covers 168,069 devices globally, and the FDA has classified it as a Class I recall.

The recall was issued because supercapacitor electrolyte leakage on the printed circuit board assembly (PCBA) can damage the charger chip. This damage may cause the ventilator to enter a fail-safe state and interrupt ventilation therapy.

The affected devices were distributed nationwide in the United States and in many countries worldwide. The recall notice includes specific UDI-DI codes and serial-number ranges for identifying affected ventilators and spare parts.

Patients, caregivers, and providers should check the FDA recall notice to determine whether their device is affected and follow the instructions in the notice.

The recalled product

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
ResMed Ltd.
Category
Medical Device — Ventilator / Respiratory Support
Hazard
Affected units
168,069

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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