Class II — Southmedic, Inc.
| Recalling firm | SOUTHMEDIC, INC. |
|---|---|
| Registered facility | SOUTHMEDIC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient. |
| Product | OxyMask O2 Adult REF OM-1125-14 |
| Quantity | 160 cases (25 units per case) in U.S. |
| Distribution | U.S.: IL O.U.S.: N/A |
| Initiated | 2021-05-25 |
| Classified | 2021-07-23 |
| Recall number | Z-2141-2021 |
| 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-2141-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88103/
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