Use caution Medical device recall · FDA · Published November 11, 2020

Westmed Adult O2/CO2 Mask Recall: Loose Connection Risk

Westmed recalls adult oxygen/CO2 masks with potential loose connections causing delayed treatment. Affected units have specific model and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0746-2021Medical device Westmed ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmWestmed, Inc.5580 S Nogales Hwy Ste 170 · Tucson, AZ 85706-3333

✎ GovInfoNow plain-language explainer

Westmed is recalling adult oxygen/CO2 masks that may have loose connections between the oxygen tube and mask adapter. This could delay treatment during medical use. Owners should check their product details and follow the official recall steps. Read more at govinfonow.com/recall/63932-westmed-adult-o2-co2-mask-recall-loose-connection-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63932-westmed-adult-o2-co2-mask-recall-loose-connection-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0746-2021

Cite this page

“Westmed Adult O2/CO2 Mask Recall: Loose Connection Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63932-westmed-adult-o2-co2-mask-recall-loose-connection-risk. Based on FDA recall #Z-0746-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2021%22&limit=1).

The FDA announced on November 11, 2020, that Westmed, Inc. is recalling REF 0562 Adult Elongated O2/CO2 Masks due to a potential loose fitment between the oxygen delivery tube and mask adapter. This defect could result in a delay in treatment for patients using the device.

How to tell if you have it

Brand: Westmed
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
UPC: 00709078001697
Lot #: 090820N30
Quantity: 6000 units

The hazard

The fitment between the oxygen delivery tube and the mask adapter may become loose, resulting in tubing not making a secure connection. This could cause a possible delay in treatment for patients receiving oxygen therapy.

Context

GovInfoNow's records show Westmed, Inc. has two other recalls on record since January 15, 2019. Other recent recalls of similar products include Medline Oxygen Masks Recall (November 21, 2025), Baxter Blue Ventilator Adapter Module Recall (February 18, 2026), and Datex-Ohmeda Aisys CS2 Anesthesia System Recall (July 30, 2026).

How to tell if you have this one

Check for the model number REF 0562 on the product. The specific lot number is 090820N30. This mask is intended for medical use only with oxygen therapy.

Brand
Westmed
Product
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
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

Recall number	Product, codes & lots	Quantity
Z-0741-2021	REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.; Lot # 091120N53	3000 units
Z-0742-2021	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.; Lot # 081120N42, 090220N29, 091020N88	37,300 units
Z-0743-2021	REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.; Lot # 091620N04	600 units
Z-0744-2021	REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.; Lot # 091720N71 (Distributed outside US)	1200 units
Z-0745-2021	REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.; Lot # 081920N38 (Distributed outside US)	16,000 units
Z-0746-2021	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.; Lot # 090820N30	6000 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number REF 0562 and lot number 090820N30 on the device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Illinois, Kansas, Maryland, Minnesota, Missouri, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Nov 11, 2020Firm started the recall
Dec 29, 2020FDA classified it Class II
Jan 6, 2021Published in FDA’s Enforcement Report
Feb 7, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this mask?

The recall requires checking product details and following the official steps, but no specific remedy is stated in the record.

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Link to this recall

<a href="https://govinfonow.com/recall/63932-westmed-adult-o2-co2-mask-recall-loose-connection-risk">Westmed Adult O2/CO2 Mask Recall: Loose Connection Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0746-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0746-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.