FDA Device recall Z-0478-2025
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1
- 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 #AS200-1 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-0478-2025 |
| 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 #AS200-1.
Reason
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Identifiers
| code_info | UDI-DI: M766AS20010; Serial numbers: CBB5224380296, CBB5224380292, CBB5224380285, CBB5224380284, CBB5224380283, CBB5224…UDI-DI: M766AS20010; Serial numbers: CBB5224380296, CBB5224380292, CBB5224380285, CBB5224380284, CBB5224380283, CBB5224380281, CBB5224380279, CBB5224380278, CBB5224380277, CBB5224380276, CBB5224380273, CBB5224380271, CBB5224380270, CBB5224380268, CBB5224380267, CBB5224380266, CBB5224380264, CBB5224380263, CBB5224380262, CBB5224380257, CBB5224380256, CBB5224380250, CBB5224380248, CBB5224380246, CBB5224380245, CBB5224380244, CBB5224380063, CBB5224380062, CBB5224380061, CBB5224380059, CBB5224380058, CBB5224380057, CBB5224380056, CBB5224380053, CBB5224380052, CBB5224380051, CBB5224380050, CBB5224380049, CBB5224380048, CBB5224380047, CBB5224380046, CBB5224380044, CBB5224380043, CBB5224380042, CBB5224380041, CBB5224380040, CBB5224380039, CBB5224380038, CBB5224380037, CBB5224380036, CBB5224380035, CBB5224380034, CBB5224380033, CBB5224380032, CBB5224380031, CBB5224380030, CBB5224380029, CBB5224380028, CBB5224380027, CBB5224380026, CBB5224380025, CBB5224380023, CBB5224380022, CBB5224380021, CBB |
|---|
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-0478-2025%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.