Astral 100 and Astral 150 ventilators — Class I medical device recall Z-0111-2024
Ongoing recall by ResMed Ltd., reported 2023-11-01, distributed nationwide. If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low batt
| Recall number | Z-0111-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ResMed Ltd., Bella Vista, N/A, Australia |
| Recall initiated | 2023-09-13 |
| Classified | 2023-10-23 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CL, CO, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, MX, MY, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, TH, TN, TR, TW, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 00619498003259, 00619498003266 |
| Serial numbers | 22151234567, 3RD, 4TH |
Product
Astral 100 and Astral 150 ventilators
Reason for recall
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all
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-0111-2024. 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.