OxyMask O2 Adult REF OM-1125-14 — Class II medical device recall Z-2141-2021
Ongoing recall by Southmedic, Inc., reported 2021-08-04, distributed in IL. Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device
| Recall number | Z-2141-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southmedic, Inc., Barrie, N/A, Canada |
| Recall initiated | 2021-05-25 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Distributed | IL |
| Lot numbers | W73887 |
| Model numbers | OM-1125-14 |
Product
OxyMask O2 Adult REF OM-1125-14
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2141-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.