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.
“Southmedic OxyMask O2 Adult REF OM-112: Oxygen tubing may disconnect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62488-southmedic-oxymask-o2-adult-ref-om-112-oxygen-tubing-may. Based on FDA recall #Z-2141-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2141-2021%22&limit=1).
Southmedic, Inc. voluntarily recalled the OxyMask O2 Adult (REF OM-1125-14) on May 25, 2021, according to the FDA. The device poses a hazard because oxygen tubing may disconnect or loosen, resulting in a loss of function and potential lack of oxygen delivery to patients.
How to tell if you have it
Brand: Southmedic
Product: OxyMask O2 Adult
REF: OM-1125-14
Model: OM-1125-14
Lot Number: W73887
Quantity: 160 cases (25 units per case) in U.S.
Distribution: Illinois
The hazard
The recall addresses the potential for oxygen tubing to disconnect from the mask or loosen. This disconnection results in a loss of device function and could lead to inappropriate or a lack of oxygen delivery to the patient.
Context
GovInfoNow's records show Southmedic, Inc. has issued three other recalls since October 17, 2017. On October 27, 2022, the company recalled safety cartridges because non-sterile products were sold as sterile. In November 2017, Southmedic recalled sterile scalpels for the same non-sterile risk. Other recent recalls of similar products include Medline Oxygen Masks Recall (November 21, 2025) and NOXBOX Nitric Oxide Delivery System Recall (August 19, 2026).
How to tell if you have this one
Check for the model number OM-1125-14 on the device. The product was sold with lot number W73887.
Brand
Southmedic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device
Look for the model number OM-1125-14 on the device or packaging.
Where it went and when
Where it was distributed
Distributed in Illinois.
Listed by the agency
Not listed
FDA distribution: “U.S.: IL O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2141-2021 (May 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2141-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.