Class II — Potential Health Hazard

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

OxyMask O2 Adult REF OM-1125-14 Recalled by Southmedic, Inc. Due to Potential for oxygen tubing to disconnect from mask...

Date: May 25, 2021
Company: Southmedic, Inc.
Status: Ongoing
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

OxyMask O2 Adult REF OM-1125-14

Quantity: 160 cases (25 units per case) in U.S.

Why Was This Recalled?

Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

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