CAIRE FreeStyle Comfort portable oxygen concentrator — Class II medical device recall Z-0478-2025
Completed recall by Caire, Inc., reported 2024-11-27, distributed nationwide. Potential failure of affected units to recharge the battery of the oxygen concentrators.
| Recall number | Z-0478-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caire, Inc., Ball Ground, GA, United States |
| Recall initiated | 2024-10-04 |
| Classified | 2024-11-15 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL, PE |
| Quantity | 739 concentrators |
| Serial numbers | CBB5221310366, CBB5224300234, CBB5224350297, CBB5224350359, CBB5224350782, CBB5224350785, CBB5224350786, CBB5224350787, CBB5224350791, CBB5224350793, CBB5224350795, CBB5224350797, CBB5224350801, CBB5224350802, CBB5224350813, CBB5224350815, CBB5224350818, CBB5224350821, CBB5224350822, CBB5224350827, CBB5224360004, CBB5224360005, CBB5224360025, CBB5224360029, CBB5224360032 and 475 more |
| Model numbers | AS200-1 |
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Reason for recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
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-0478-2025. 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.