The Recall Desk
HighFDA (Devices)·Z-0745-2021·Announced 2021-01-06

Westmed Adult Elongated Oxygen Mask Recalled for Loose Fitment

Westmed is recalling 16,000 adult elongated oxygen masks because the tube connection may become loose, potentially delaying oxygen therapy.

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 (medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Westmed, Inc. is recalling 16,000 units of the REF 0562K Adult Elongated O2/CO2 Mask. The device is intended to connect with an oxygen source to deliver oxygen therapy to patients.

The recall is due to a potential fitment issue where the oxygen delivery tube and the mask adapter may become loose. This could result in the tubing not making a secure connection to the mask adapter, which may lead to a possible delay in treatment.

The affected units were distributed worldwide, including nationwide in the United States and in Canada, Korea, and the United Kingdom. Specific US states mentioned include PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, and MN. The source text identifies Lot # 081920N38 as distributed outside the US. Consumers should stop using the device and contact Westmed for instructions.

The recalled product

Product
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Manufacturer
Westmed, Inc.
Category
Medical Device — Oxygen Therapy
Hazard
Affected units
16,000

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 # 081920N38 (Distributed outside US)

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.

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Same hazard · loose connection

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