FDA Device recall Z-0479-2025
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101
- FDA Device
- Class II
- completed
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101 by Caire, citing potential failure of affected units to recharge the battery of the oxygen concentrators.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0479-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-10-04 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Caire |
| Distribution | US |
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Reason
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Identifiers
| code_info | UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5…UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0479-2025%22
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