Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8 Recalled by Southmedic, Inc. Due to Potential for loose or missing CO2 diffusers which...

Date: October 17, 2017
Company: Southmedic, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Southmedic, Inc. directly.

Affected Products

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.

Quantity: 8,871 cases (25 masks per case) total

Why Was This Recalled?

Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

Where Was This Sold?

US Distribution to the state of California, and Internationally to Canada and Sweden

About Southmedic, Inc.

Southmedic, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report