Southmedic Oxygen Masks with EtCO2 Sampling Line: Potential for Non-Functioning Mask
Southmedic recalls oxygen masks with EtCO2 sampling line (part number OM-2125-8) due to potential loose or missing CO2 diffusers causing non-functioning. Affected units include specific model numbers and lot codes.
Lower-risk recall
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
Contact the company
What happened, in plain English
Southmedic is recalling oxygen masks with EtCO2 sampling lines (part number OM-2125-8) because loose or missing CO2 diffusers might cause the mask to not work properly. This could affect medical users who rely on accurate breathing monitoring. Read more at govinfonow.com/recall/72823-southmedic-oxygen-masks-with-etco2-sampling-line-potential-for-non.
Source Summary by GovInfoNow · govinfonow.com/recall/72823-southmedic-oxygen-masks-with-etco2-sampling-line-potential-for-non · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1288-2018
Cite this page
“Southmedic Oxygen Masks with EtCO2 Sampling Line: Potential for Non-Functioning Mask.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72823-southmedic-oxygen-masks-with-etco2-sampling-line-potential-for-non. Based on FDA recall #Z-1288-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1288-2018%22&limit=1).
Why it’s dangerous
The masks may have loose or missing CO2 diffusers, which can cause the mask to stop functioning correctly. This means the device might not accurately monitor breathing, which is critical for medical patients using oxygen therapy.
Who’s affected
Medical users who own or use Southmedic oxygen masks with EtCO2 sampling lines (part number OM-2125-8) are most at risk. The recall affects specific model numbers and lot codes.
How to tell if you have this one
Check for part number OM-2125-8 on the mask. Affected units include specific model numbers and lot codes listed in the recall notice, such as W40056, W40161, and others.
- Brand
Southmedic- Category
Medical device
What to do — step by step
Check Mask Part Number
Look for part number OM-2125-8 on the mask to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in California, and outside the U.S.
FDA distribution: “US Distribution to the state of California, and Internationally to Canada and Sweden” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA terminated this recall 6.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the mask?
No immediate action is required beyond checking the part number. The recall does not require stopping use but ensures proper functioning.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1288-2018 (October 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1288-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.