FDA Device recall Z-0805-2020
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administr…
- FDA Device
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administr… by Caire, citing four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0805-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-21 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Caire |
| Distribution | US |
Product
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Reason
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Identifiers
| code_info | Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2020%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.