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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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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