Recall Z-2735-2026— ResMed Ltd.
Class I · Ongoing
Class I FDA medical device recall by ResMed Ltd., initiated 2026-06-25. It names 2 FDA 510(k) clearances: K172875, K152068. 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..
- Recalling firm
- ResMed Ltd.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-06-25
- Firm location
- Bella Vista, N/A, Australia
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.