Westmed, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0745-2021)

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:

REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

Product Classification:

Class II

Date Initiated: November 11, 2020

Date Posted: January 6, 2021

Recall Number: Z-0745-2021

Event ID: 86903

Reason for Recall:

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Status: Terminated

Product Quantity: 16,000 units

Code Information:

Lot # 081920N38 (Distributed outside US)

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated