The Recall Desk
HighFDA (Devices)·Z-0746-2021·Announced 2021-01-06

Westmed Adult Oxygen Mask Recall Due to Potential Loose Fitment

Westmed is recalling 6,000 units of Adult Elongated O2/CO2 Masks because the oxygen delivery tube may not connect securely to the mask adapter, potentially delaying treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where a loose connection could delay treatment, but no injuries or illnesses have been reported, fitting the criteria for a High severity score.

Plain-English summary

Westmed, Inc. is recalling 6,000 units of REF 0562 Adult Elongated O2/CO2 Masks. The recall is due to a potential issue where 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, which may lead to a possible delay in treatment.

The affected product is intended to connect with an oxygen source to deliver oxygen therapy to the patient. The recall includes Lot # 090820N30. Distribution was worldwide, including US nationwide distribution in states such as PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, MN, and KS, as well as in Canada, Korea, and the United Kingdom.

Consumers should stop using the affected masks and contact Westmed, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Manufacturer
Westmed, Inc.
Category
Medical Device — Oxygen Therapy Equipment
Hazard
Affected units
6,000

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 (1)

  • Lot # 090820N30

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Westmed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Westmed, Inc.

See all →

Same hazard · loose connection

See all →