Southmedic Oxygen Masks Recalled Due to Potential CO2 Diffuser Issues
Southmedic, Inc. is recalling specific oxygen masks with EtCO2 sampling lines because loose or missing CO2 diffusers may render the masks non-functioning.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional defect (non-functioning mask) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Southmedic, Inc. is recalling Southmedic Oxygen Masks with EtCO2 sampling lines, part number OM-2125-8, and related variants. The recall involves 8,871 cases, with 25 masks per case. These devices are minimal contact, open oxygen delivery systems used with USP medical grade oxygen to monitor breathing by sampling exhaled CO2.
The recall was initiated due to a potential for loose or missing CO2 diffusers, which could result in a non-functioning mask. The affected products were distributed in the United States to the state of California, and internationally to Canada and Sweden.
Consumers and healthcare facilities should stop using the affected masks and contact Southmedic, Inc. for further instructions or a replacement. The specific lot numbers and part numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
- Manufacturer
- Southmedic, Inc.
- Category
- Medical Device — Oxygen Delivery
- 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 (20)
- Part No. (Lot No.)
- OM-2125-8 (W40056
- W40161
- W40162
- W40317
- W40556
- W40645
- W40668)
- OK-2125-8 (W37602
- W37898
- W39852
- W40051
- W40863)
- OK-2125-8SLM (W36957
- W39164
- W39695
- W41454)
- OM-2125-14 (W36512
- W38338)
- OM-2125-14SLM (W35876
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Southmedic, Inc.
See all →- HighSurgical Blade Safety Cartridges Recalled Due to Missing Sterilization
FDA (Devices) · 2022-11-30
- HighOxyMask O2 Adult oxygen tubing disconnect hazard recalled
FDA (Devices) · 2021-08-04
- HighSouthmedic Recalls Sterile Scalpels Labeled as Non-Sterile
FDA (Devices) · 2018-05-23
Same hazard · malfunction
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
- SevereElectric Start Pressure Washers Recalled for Carbon Monoxide Hazard
CPSC · 2026-05-14