FDA Device recall Z-1117-2022
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- FDA Device
- Class II
- terminated
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 by Caire, citing the device was not cleared for U.S. distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1117-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-25 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Caire |
| Distribution | PR |
Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Reason
The device was not cleared for U.S. distribution.
Identifiers
| code_info | Serial numbers CBB5221200337 and CBB5221200287. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1117-2022%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.