(Reuters) – The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of certain respiratory masks made by ResMed as most serious as their use could cause major injuries or death.
ResMed was recalling some models of its 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 were intended for use in certain patients who have been prescribed non-invasive positive airway pressure (PAP) therapy, which uses a machine to pump air under pressure into the airway of the lungs, according to the health regulator.
The FDA said ResMed was recalling these masks to update the labels and add more warnings and information.
The California-based 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 has been six reported injuries and no reports of death due to the devices.
The devices were distributed between January 2020 and Nov. 20, 2023.
(Reporting by Mariam Sunny in Bengaluru; Editing by Maju Samuel)
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