Agency classClass IIOur severity:High FDA (Devices)·Z-0742-2021·Announced 2021-01-06

Westmed Non-Rebreather Masks Recalled for Loose Oxygen Tube Fitment

Westmed is recalling 37,300 non-rebreather masks because the oxygen tube connection may become loose, potentially delaying patient treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a defect could delay treatment, but no injuries or illnesses have been reported, fitting the 'High' severity criteria.

Plain-English summary

Westmed, Inc. is recalling 37,300 units of Westmed Disposable Respiratory Products Non-Rebreather Masks (Ref 3228-e). The affected products are prescription-only devices intended to connect with an oxygen source to deliver oxygen therapy to patients. The recall covers specific lots: 081120N42, 090220N29, and 091020N88.

The recall was initiated because there is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This defect 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 products were distributed worldwide, including nationwide in the United States and in Canada, Korea, and the United Kingdom. Specific U.S. states mentioned in the distribution pattern include Pennsylvania, Oklahoma, Missouri, Colorado, Rhode Island, Illinois, California, Texas, Ohio, Maryland, Minnesota, and Kansas. Patients and healthcare providers should stop using the affected masks and contact Westmed, Inc. for further instructions or replacement.

The recalled product

Product: Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Manufacturer: Westmed, Inc.
Category: Medical Device — Respiratory Equipment
Hazard: loose-connection
delayed-treatment
Affected units: 37,300

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 (3)

Lot # 081120N42
090220N29
091020N88

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 →

Same manufacturer · Westmed, Inc.

See all →

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Same hazard · loose connection