Southmedic, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2141-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

OxyMask O2 Adult REF OM-1125-14

Product Classification:

Class II

Date Initiated: May 25, 2021

Date Posted: August 4, 2021

Recall Number: Z-2141-2021

Event ID: 88103

Reason for Recall:

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.

Status: Ongoing

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

Code Information:

Model: OM-1125-14 Lot Number: W73887

Distribution Pattern:

U.S.: IL O.U.S.: N/A

Voluntary or Mandated:

Voluntary: Firm initiated