The U.S. Food and Drug Administration (FDA) has recently elevated the recall status of specific respiratory masks produced by ResMed (RMD.N) to its highest level of concern, citing the potential for severe injuries or fatalities from their use. This urgent recall involves certain models of ResMed’s continuous positive airway pressure (CPAP) masks, specifically the AirFit and AirTouch series. The FDA has identified risks associated with these masks due to potential magnetic interference with various medical devices and implants. Such interference could alter the function or positioning of these devices, leading to serious health risks or even death. These masks are primarily designed for patients undergoing non-invasive positive airway pressure (PAP) therapy, a treatment that involves using a machine to deliver pressurized air into the lungs. ResMed’s recall aims to update product labels and enhance warnings and informational content. The recall, initiated on November 20 by the California-based medical device manufacturer, has led to the withdrawal of over 20 million devices across the United States.
