CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator — Class II medical device recall Z-0805-2020
Terminated recall by Caire, Inc., reported 2020-01-22, distributed nationwide. Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in t
| Recall number | Z-0805-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caire, Inc., Ball Ground, GA, United States |
| Recall initiated | 2019-11-21 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2020-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | unapproved product |
| Serial numbers | CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280 |
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 for recall
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0805-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.