FDA Device recall Z-0481-2025
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2
- 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 #AS200-2 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-0481-2025 |
| 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 #AS200-2.
Reason
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Identifiers
| code_info | No UDI-DI (for export only); Serial numbers: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710,…No UDI-DI (for export only); Serial numbers: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710, CBB5224350653, CBB5224350648, CBB5224350636, CBB5224350606, CBB5224350583, CBB5224350580, CBB5224350575, CBB5224350573, CBB5224350567, CBB5224350512, CBB5224350510, CBB5224350509, CBB5224350508, CBB5224350498, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459. |
|---|
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-0481-2025%22
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