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 | The device was not cleared for U.S. distribution. |
| Product | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 |
| Quantity | 2 oxygen concentrators |
| Distribution | Distribution was made to Puerto Rico. There was no foreign/government/military distribution. |
| Initiated | 2022-03-25 |
| Classified | 2022-05-19 |
| Terminated | 2023-10-05 |
| Recall number | Z-1117-2022 |
| 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-1117-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90011/
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