The Food and Drug Administration on Thursday classified the voluntary recall of certain respiratory masks made by ResMed as “most serious” as their incorrect use could cause major injuries or death.
The San Diego-based medical device maker said the recall involved a correction in product labeling and is not a product removal.
The recall involves some models of ResMed’s continuous positive airway pressure (CPAP) masks, AirFit and AirTouch, due to possible magnetic interference with certain medical devices and implants which might disrupt their function or position and cause serious harm or death, the FDA said.
The masks are intended for use by patients who have been prescribed non-invasive positive airway pressure therapy, which uses a machine to pump air under pressure into the airway of the lungs to treat sleep apnea, according to the health regulator.
ResMed’s masks remain safe to be used when kept at a distance of at least 6 inches away from implants or medical devices that could be adversely affected by magnetic interference.
The medical device maker started the recall process on Nov. 20 and has recalled over 20 million devices in the United States.
The health regulator said there have been six reported injuries and no reports of death due to the devices.
The devices were distributed between January 2020 and Nov. 20, 2023.
Updated at 12:45 p.m., Wednesday, Jan. 17, 2024
