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ResMed Ltd.

Complete recall history across all FDA and CPSC categories — 10 total recalls

ResMed Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by ResMed Ltd.

Date Product Reason Class
Nov 20, 2023 AirFit N20 Nasal Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Nov 20, 2023 AirFit F30i Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Nov 20, 2023 AirFit F20 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Nov 20, 2023 AirFit N10 Nasal Masks and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Nov 20, 2023 AirFit F30 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Nov 20, 2023 AirTouch N20 Nasal Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Nov 20, 2023 AirTouch F20 Full Face Mask and User Guide Masks non-invasive interface for channeling airflow to patients have magnets ... Class I
Sep 13, 2023 Astral 100 and Astral 150 ventilators If ventilator is on internal battery, not intended to serve as a primary powe... Class I
Dec 12, 2019 ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 Combination of software and a component failure may cause audible alarms not ... Class I
May 5, 2015 Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. The Astral device allows clinicians to disable all alarms including those tha... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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