Astral 100 — Class II medical device recall Z-0746-2016
Terminated recall by Resmed Corporation, reported 2016-02-10, distributed in AR, AZ, CA, CO, CT, DE, FL, GA…. Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
| Recall number | Z-0746-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resmed Corporation, San Diego, CA, United States |
| Recall initiated | 2016-01-13 |
| Classified | 2016-02-03 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-04-22 |
| Distributed | AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, WV, WY |
| Quantity | 14,736 |
| Serial numbers | 22141256783, 22141256787, 22141256793, 22141256800, 22141256808, 22141256809, 22141256810, 22141256812, 22141256813, 22141269796, 22141269837, 22141269858, 22141269861, 22141269862, 22141269866, 22141269867, 22141269869, 22141269872, 22141269874, 22141269878, 22141269879, 22141269881, 22141269882, 22141269883, 22141269887 and 475 more |
| Model numbers | 27001, 27003 |
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.
Reason for recall
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
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-0746-2016. 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.