Southmedic Oxygen Masks with EtCO2 sampling line part… recallZ-1288-2018 · Southmedic, Inc. · initiated Oct 17, 2017
Class II Terminated All recalls posted in January 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Southmedic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
FDA root cause category: Device Design
What the company is doing
Customers were notified via letter on October 17, 2017. Instructions included checking inventory for affected devices and quarantining any found, complete and return the Voluntary Recall Notification Confirmation Form, and arrange for the return of any affected products. On February 14, 2018, the recall was expanded and customers were notified. Instructions were the same as the original notification, but updated the Part/Lot information. For further questions, please call 1 (800) 463-7146
Recall details
- Recall number
- Z-1288-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 17, 2017
- Posted by the FDA
- Jan 25, 2018
- Recalling firm
- Southmedic, Inc.
- Quantity
- 8,871 cases (25 masks per case) total
- Product code
- CCK
- FDA submissions
- K014211
- Distribution
- US Distribution to the state of California, and Internationally to Canada and Sweden
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.
Code information (models, lots, serial numbers)
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)
Other devices under the same FDA submission
1 device cleared under K014211 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OxyMask™ O2/EtCO2 Adult Mask with Microstream™ connector OM-2125-MDTSouthmedic Incorporated · ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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