Last month, ResMed (NYSE: RMD) warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body.
People using CPAP masks with magnets only need to return them if they’re contraindicated. ResMed instead instructed people using the masks to keep the magnets at least 6 in. away from implants or medical devices that could be affected — and to check with physicians and device makers about whether magnetic fields could negatively affect an implant.
ResMed also has an updated webpage with information about the potential problems.
More about the ResMed CPAP masks recall
In its announcement yesterday of the Class I designation, the FDA said that the recall involves 20.4 million AirFit and AirTouch masks distributed in the U.S. from January 2020 to November 20, 2023. (The FDA lists product codes and model numbers on its website.)
The FDA said there have been six reported injuries related to mask magnets potentially interfering with the operation of other devices. There have been no reports of death.
Competitor Philips — which remains out of the CPAPs market as it grapples with a host of recalls — had a similar recall related to magnets and implanted devices just over a year ago.
