Astral 100 — Class II medical device recall Z-1750-2015
Terminated recall by ResMed Ltd., reported 2015-06-17, distributed nationwide. The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. I
| Recall number | Z-1750-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ResMed Ltd., Bella Vista, NSW, N/A, Australia |
| Recall initiated | 2015-05-05 |
| Classified | 2015-06-10 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, UY |
| Quantity | 1,519 units |
| Serial numbers | 22141256746, 22141256747, 22141256749, 22141256750, 22141256752, 22141256753, 22141256754, 22141256755, 22141256756, 22141256757, 22141256758, 22141256759, 22141256760, 22141256761, 22141256762, 22141256763, 22141256764, 22141256765, 22141256766, 22141256767, 22141256768, 22141256770, 22141256771, 22141256773, 22141256774 and 475 more |
| Model numbers | 27001, 27003 |
Product
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Reason for recall
The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.
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-1750-2015. 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.