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Use caution Medical device recall · FDA · Published May 25, 2021

Southmedic OxyMask O2 Adult REF OM-112: Oxygen tubing may disconnect

Southmedic recalls OxyMask O2 Adult REF OM-1125-14 due to risk of oxygen tubing disconnecting, causing inadequate oxygen delivery to patients.

🇺🇸 FDA recall #Z-2141-2021Medical deviceSouthmedic ›
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Recalling firmSouthmedic, Inc.50 Alliance Blvd · Barrie, Canada
✎ GovInfoNow plain-language explainer

Southmedic is recalling OxyMask O2 Adult REF OM-1125-14 because the oxygen tubing might disconnect from the mask, leading to insufficient oxygen delivery for patients. This could cause harm if the device stops working during use. Read more at govinfonow.com/recall/62488-southmedic-oxymask-o2-adult-ref-om-112-oxygen-tubing-may.

Source Summary by GovInfoNow · govinfonow.com/recall/62488-southmedic-oxymask-o2-adult-ref-om-112-oxygen-tubing-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2141-2021

Cite this page

“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

  1. 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.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

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.

1. Firm started the recall: May 25, 202112. FDA classified it Class II: Jul 23, 202123. Published in FDA’s Enforcement Report: Aug 4, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA