Class I — 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 I |
| Status | Terminated |
| Reason | An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. |
| Product | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit |
| Quantity | 10 devices |
| Distribution | US Nationwide - Worldwide Distribution: CA, NC, OH, AZ, and Canada, Chile, Colombia, and Germany |
| Initiated | 2022-10-10 |
| Classified | 2022-12-02 |
| Terminated | 2024-08-19 |
| Recall number | Z-0336-2023 |
| 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 I recall — Caire, Inc. (Z-0336-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90999/
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