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 | There is an electronics control issue that causes the unit to not power on with battery power only. |
| Product | SAROS Oxygen System Model 3000 |
| Quantity | 10 units |
| Distribution | US and Chile |
| Initiated | 2019-09-16 |
| Classified | 2019-10-30 |
| Terminated | 2020-12-16 |
| Recall number | Z-0248-2020 |
| 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-0248-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83850/
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