Class II — Caire, Inc.
| Recalling firm | CAIRE Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the 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. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of MI, CA, CT. |
| Initiated | 2019-11-21 |
| Classified | 2020-01-13 |
| Terminated | 2020-11-20 |
| Recall number | Z-0805-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Caire, Inc. (Z-0805-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84512/
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