Class II — ResMed Ltd.
| Recalling firm | RESMED CORP. |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. |
| Quantity | 1519 units |
| Distribution | Worldwide distribution. US nationwide, Uruguay and Canada. |
| Initiated | 2015-05-05 |
| Classified | 2015-06-10 |
| Terminated | 2016-04-07 |
| Recall number | Z-1750-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ResMed Ltd. (Z-1750-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71100/
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