On Thursday, ResMed Ltd (NYSE:RMD) disclosed a recall of its Continuous Positive Airway Pressure (CPAP) masks with magnets, citing possible magnetic interference with certain medical devices. The company is recalling the masks to update labels and add more warnings and information to guide patients and healthcare professionals on safe usage when using masks with magnets.

Under certain circumstances, the magnetic interference could disrupt the function or position of medical implants and devices, potentially leading to serious harm or death. As a result, the FDA has designated this as a Class I recall, the most serious type of recall.

ResMed’s existing labels advise keeping magnets 2 inches away from affected medical devices. However, the labels do not specify all the specific devices that could be affected by the masks’ magnets, necessitating an update.

The need for this recall and label update arose from a review of potential risks associated with magnetic interference to medical implants. ResMed has initiated the recall process and has recalled over 20 million devices in the U.S. since November 20, 2023.

The recalled AirFit and AirTouch masks, non-continuous ventilatory devices, are intended for patients weighing more than 66 lbs. who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. These masks are designed for reuse by one person at home or by multiple people in hospitals. The masks feature magnets on the lower headgear straps and frame connections to enhance wearing comfort.

Despite the advisory to keep the magnets at a safe distance of six inches (150 mm) away from affected implants or devices, the use of affected masks may cause serious adverse health consequences, as evidenced by the six reported injuries to date. There have been no reports of death associated with the use of these affected masks.

As a result of this recall, RMD shares are down 0.47% at $177.06 at the last check on Friday.