There is a risk of serious injury or death related to more than 20 million CPAP masks made by ResMed, the FDA said Jan. 11.
The continuous positive airway pressure masks, branded as AirFit and AirTouch, have magnets on the headgear to make the device comfortable. ResMed's labels advise keeping magnets at least 2 inches away from the mask, but the label "doesn't list all the specific ones that could be affected by the masks' magnets," the FDA said.
If a magnet is less than 2 inches away from the CPAP mask, the proximity can disrupt the functions of other medical implants and devices. ResMed has received six reports of injuries but no reports of death.
The masks are intended for reuse by one patient at home or by multiple people in hospitals, according to the agency. ResMed is alerting consumers of all 20,414,357 masks about the issue.
The FDA issued a Class I recall for the product, but the agency clarified it as a warning and not a product removal.