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 | Completed |
| Reason | Potential failure of affected units to recharge the battery of the oxygen concentrators. |
| Product | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. |
| Quantity | 23 concentrators |
| Distribution | Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru. |
| Initiated | 2024-10-04 |
| Classified | 2024-11-15 |
| Recall number | Z-0479-2025 |
| 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-0479-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95576/
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