Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8 — Class II medical device recall Z-1288-2018
Terminated recall by Southmedic, Inc., reported 2018-04-11, distributed in CA. Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
| Recall number | Z-1288-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Southmedic, Inc., Barrie, N/A, Canada |
| Recall initiated | 2017-10-17 |
| Classified | 2018-04-02 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2024-03-29 |
| Distributed | CA |
| Countries outside the US | CA, SE |
| Lot numbers | OK-2125-8, OK-2125-8SLM, OM-2125-14, OM-2125-14SLM, OM-2125-8, OM-2125-8SLM, OP-2125-14, OP-2125-8, OP-2125-8SLM, W36433, W37099, W37342, W37488, W37605, W37741, W37742, W37743, W37898, W37899, W37998, W38005, W38190, W38477, W38641, W38692, W38700, W38905, W39023, W39027, W39164, W39251, W39252, W39253, W39545, W39695, W39850, W39852, W40051, W40056, W40161 and 4 more |
| Model numbers | OK-2125-8, OK-2125-8SLM, OM-2125-14, OM-2125-14SLM, OM-2125-8, OM-2125-8SLM, OP-2125-14, OP-2125-8, OP-2125-8SLM, W36433, W37099, W37342, W37488, W37605, W37741, W37742, W37743, W37898, W37899, W37998, W38005, W38190, W38477, W38641, W38692 and 19 more |
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.
Reason for recall
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
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-1288-2018. 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.