Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system… — Class I medical device recall Z-2735-2026
Ongoing recall by ResMed Ltd., reported 2026-08-05, distributed nationwide. Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger ch
| Recall number | Z-2735-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ResMed Ltd., Bella Vista, N/A, Australia |
| Recall initiated | 2026-06-25 |
| Classified | 2026-07-28 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 168,069 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00619498003259, 00619498270033 |
| Serial numbers | 22241440282, 22241890149, 22241978070 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2735-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.