Class I — 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 I |
| Status | Completed |
| Reason | Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch. |
| Product | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 |
| Quantity | 69 |
| Distribution | U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT |
| Initiated | 2019-12-12 |
| Classified | 2020-02-06 |
| Recall number | Z-0915-2020 |
| 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 I recall — ResMed Ltd. (Z-0915-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84551/
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