FDA Device recall Z-0480-2025
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103
- 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 #AS200-103 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-0480-2025 |
| 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 #AS200-103.
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 CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582. |
|---|
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-0480-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.