Class II — Resmed Corporation
| 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 | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. |
| Product | Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care. |
| Quantity | 14,736 |
| Distribution | Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR. |
| Initiated | 2016-01-13 |
| Classified | 2016-02-03 |
| Terminated | 2016-04-22 |
| Recall number | Z-0746-2016 |
| 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 Corporation (Z-0746-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73071/
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