Southmedic, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1288-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 17, 2017

Date Posted: April 11, 2018

Recall Number: Z-1288-2018

Event ID: 78568

Reason for Recall:

Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

Status: Terminated

Product Quantity: 8,871 cases (25 masks per case) total

Code Information:

Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)

Distribution Pattern:

US Distribution to the state of California, and Internationally to Canada and Sweden

Voluntary or Mandated:

Voluntary: Firm initiated