On January 12, 2024, the U.S. Food and Drug Administration (FDA) classified a recall on certain ResMed CPAP masks as Class I1, their most serious category.
ResMed originally issued the recall on November 20, 2023. Their recall involves the following products distributed between January 2020 to November 20, 2023:
- AirFit N10
- AirFit F20
- AirTouch F20
- AirFit N20
- AirTouch N20
- AirFit F30
- AirFit F30i
The reason for the recall is that ResMed is updating the labels and warnings on the aforementioned products as they contain magnets, which could disrupt the functionality or positioning of certain medical implants and devices. According to the FDA, the use of these masks “may cause serious adverse health consequences and death.” At this time, there have been six injuries reported and no deaths.
On December 8, 2023, ResMed sent a medical advisory notice to all the affected users.1
They also added these updated safety guidelines2 on their website. In their guidelines, ResMed warns users to keep the mask magnets at least 6 inches away from implants or medical devices that could be negatively impacted.
The guidelines apply to those who either have a medical implant or device that could be impacted by the magnets or if they come into “close physical contact” with someone who does. ResMed provided the following examples of items that could be impacted by magnetic CPAP masks:
- Implantable cardioverter defibrillators (ICD)
- Cerebrospinal fluid (CSF) shunts
- Insulin/infusion pumps
- Aneurysm clips/flow disruption devices
- Embolic coils
- Implants to restore hearing or balance with implanted magnets
- Ocular implants
- Metallic splinters in the eye
If you have a medical device or implant not listed here, though, it is strongly advised that you consult your healthcare provider as soon as possible to determine if it’s safe to use a CPAP mask with magnets in it.
The FDA also says U.S. customers can contact ResMed with questions about the recall at 1-800-424-0737.
Explore our picks for the best CPAP masks if you’re in need of a new mask.
Jill Zwarensteyn is the Editor for Sleep Advisor and a Certified Sleep Science Coach. She is enthusiastic about providing helpful and engaging information on all things sleep and wellness.