The Recall Desk
HighFDA (Devices)·Z-2141-2021·Announced 2021-08-04

OxyMask O2 Adult oxygen tubing disconnect hazard recalled

Southmedic recalled OxyMask O2 Adult oxygen masks (Model OM-1125-14, Lot W73887) due to potential oxygen tubing disconnection that could interrupt oxygen delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a serious potential hazard—loss of oxygen delivery could endanger patients—but no reported injuries in the source, qualifying as a high-risk product where injury has not yet been reported.

Plain-English summary

Southmedic, Inc. recalled 160 cases of OxyMask O2 Adult masks (Model OM-1125-14, Lot W73887) distributed in Illinois. The oxygen tubing may disconnect or loosen from the mask.

When the tubing disconnects or loosens, the device loses function and cannot deliver oxygen to patients. This could result in inappropriate oxygen delivery or a complete lack of oxygen delivery, potentially compromising patient care.

The recalled product

Product
OxyMask O2 Adult REF OM-1125-14
Manufacturer
Southmedic, Inc.
Category
Medical Device — Oxygen delivery equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model: OM-1125-14 Lot Number: W73887

Distribution

Distributed in 1 state:

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