ResMed CPAP Mask Recall Issued Due To Risk Magnets May Interfere with Medical Devices

Magnets used in ResMed AirFit and AirTouch CPAP and BiPAP masks could put certain patients at risk of severe injuries or deaths, the FDA warns.

More than 20 million ResMed CPAP and BiPAP masks are being recalled, due to the risk that magnets in the masks may interfere with implanted medical devices, posing a risk of serious injury or death for users.

The U.S. Food and Drug Administration (FDA) announced the ResMed CPAP mask recall on January 11, warning that all AirFit and AirTouch face mask models contain magnets that may disrupt the operation of pacemakers, defibrillators, stents and other implanted medical devices if they come within two inches of the headset magnets.

To date, officials have become aware of at least six reported injuries caused by the headset magnets coming close to implanted medical devices.

Philips Previously Recalled CPAP Masks Due to Magnets

The risks associated with the ResMed masks are similar to problems that resulted in a massive Philips CPAP mask recall in late 2022, impacting more than 17 million full face masks and nasal masks that contained magnetic headgear clips to hold them in place, which were found to disrupt the functionality of critical medical devices in users or those nearby.

That recall came amid serious concerns about health problems from Philips CPAP machines, after millions of machines used with the masks were removed from the market in late 2021, due to a risk that sound abatement foam inside the machines may breakdown, and release toxic gases and debris directly into the air pathways and users’ CPAP masks.

There are currently tens of thousands of Philips CPAP lawsuits being pursued by former users of those machines that contained the defective sound abatement foam, involving users who developed various cancers and respiratory injuries after breathing the toxic particles. The FDA also gave the Philips CPAP mask recall a class I designation, suggestion that use of the magnetic masks may pose a risk of serious injury or death, but no known lawsuits have been filed over the magnetic interference issues.

ResMed AirFit and AirTouch CPAP Masks

The recalled ResMed AirFit and AirTouch masks are non-continuous ventilatory devices used during non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. These masks are intended for patients weighing more than 66 lbs. and can be used in a home or hospital setting.

The recall impacts an estimated 20,414,357 AirFit and AirTouch full face masks and nasal masks that contain magnets on the lower headgear straps and frame connections, which are designed to make wearing the masks more comfortable. The masks were distributed for sale to various medical supply stores, pharmacies, hospitals and other distribution channels from January 2020 to November 20, 2023, including the following models:

• AirFit N10 (Nasal mask)
• AirFit F20 (Full face mask)
• AirFit N20 (Nasal mask)
• AirFit F30 (Full face mask)
• AirFit F30i (Full face mask)
• AirTouch F20 (Full face mask)
• AirTouch N20 (Nasal mask)

According the recall, the existing AirFit and AirTouch facemasks do not list all the specific medical devices that could be affected by the masks’ magnets. As part of the recall, ResMed will be updating the label for the masks to include additional warnings and safety information for customers and healthcare professionals.

The FDA has given a Class I designation to the recall, indicating it is the most serious of its kind, and that the use of the product has a high probability or likelihood of causing serious injury or death to customers.

ResMed issued an Important Medical Device Advisory on December 8, 2023,  instructing customers to keep the magnets at least six inches away from implants or medical devices that could be affected by magnetic interference. Individuals using the recalled masks that have an implantable medical device are being encouraged to consult with their healthcare provider to evaluate the potential risk of interference.

Customers with additional questions or concerns regarding the recall are being instructed to contact ResMed at 1-800-332-1088. Individuals are also being encouraged to report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.