
The U.S. FDA categorizes the recall of certain ResMed respiratory masks as the most serious, warning of potential injuries or death. The recall involves models of continuous positive airway pressure (CPAP) masks, AirFit and AirTouch, due to possible magnetic interference affecting medical devices and implants, posing risks of harm or fatality. ResMed initiated the recall on Nov. 20, 2023, affecting over 20 million devices distributed between January 2020 and Nov. 20, 2023. The FDA reports six injuries but no deaths related to these devices. ResMed is recalling masks to update labels and provide additional warnings.
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