Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

AirFit F30i Full Face Mask and User Guide Recalled by ResMed Ltd. Due to Masks non-invasive interface for channeling airflow to patients...

Date: November 20, 2023
Company: ResMed Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ResMed Ltd. directly.

Affected Products

AirFit F30i Full Face Mask and User Guide

Quantity: 2,037,323

Why Was This Recalled?

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ResMed Ltd.

ResMed Ltd. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report