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Resmed AirFit F20 Full Face Mask and User Guide - safety alert

Official notice

27 Dec 2023

Last checked

27 Dec 2023

Critical riskFDA

An official FDA notice concerns Resmed AirFit F20 Full Face Mask and User Guide - safety alert. An official FDA notice concerns AirFit F20 Full Face Mask and User Guide. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-12-27. Recall numbers: Z-0537-2024. Check the official notice for the complete list. Published 2023-12-27.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

11,885,039

Recall number

Z-0537-2024

Official notice

2023-12-27

The hazard

An official FDA notice concerns AirFit F20 Full Face Mask and User Guide. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-12-27. Recall numbers: Z-0537-2024. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 619498634019

Event Ids

93499

Recall Numbers

Z-0537-2024

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Affected products

Product 1

AirFit F20 Full Face Mask and User Guide

Units affected

11,885,039

Risk / hazard

An official FDA notice concerns AirFit F20 Full Face Mask and User Guide. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-12-27. Recall numbers: Z-0537-2024. Check the official notice for the complete list.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia · N/A · Bella Vista

Affected area 1

AU · Australia · N/A · Bella Vista

Affected area 2

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Resmed. Contact: ResMed Ltd..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-0537-2024

Event id

93499

Units affected

11,885,039

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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