Class II — Southmedic, Inc.
| Recalling firm | SOUTHMEDIC, INC. |
|---|---|
| Registered facility | SOUTHMEDIC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. |
| Product | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2. |
| Quantity | 8,871 cases (25 masks per case) total |
| Distribution | US Distribution to the state of California, and Internationally to Canada and Sweden |
| Initiated | 2017-10-17 |
| Classified | 2018-04-02 |
| Terminated | 2024-03-29 |
| Recall number | Z-1288-2018 |
| 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 — Southmedic, Inc. (Z-1288-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78568/
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