The U.S. Food and Drug Administration (FDA) has declared the recall of continuous positive airway pressure (CPAP) masks by global sleep solution company ResMed as a significant matter related to patients' lives.

The FDA said last Thursday that the ResMed CPAP mask recall incident, which occurred last year, is a very serious issue due to its association with major injuries or deaths.

ResMed has been marketing its CPAP devices AirFit and AirTouch from Jan. 2020 to Nov. 20 of last year. These CPAP devices are medical equipment used to treat snoring and sleep apnea, functioning by delivering air through the nose to keep the airway open.

Some ResMed masks used with these devices contain magnets, enabling patients to easily attach and detach the headgear to the mask frame for routine use. The company explained that this feature is particularly beneficial for patients with disabilities, including those with manual dexterity or visual impairments.

However, with six reported injuries from patients using the masks containing magnets, ResMed issued a recall, which has been in progress since Nov. 20 last year, and so far, over 20 million units have been retrieved.

Although there have been no reported deaths due to the device, the FDA designated this recall as a Class 1 action, the highest risk level. Class 1 recalls are for situations that could potentially cause serious health problems or death.

In relation to this, ResMed Korea is not recalling the product in Korea.

Separately, ResMed Korea sent out a patient letter updating the contraindications and warnings related to magnetic interference in all user manuals for its magnetic masks.

The contraindication updates include prohibiting the use of masks with magnetic components for patients with implanted medical devices, metal implants that interact with magnets, or those in close physical contact with the mask wearer.

Additionally, the warning update states that a minimum safety distance of 6 inches (15 cm) must be maintained from any implant or medical device that could be adversely affected by magnetic interference.

ResMed Korea stressed that their magnetic masks are safe when used according to the updated guidelines, and patients affected will be provided with alternative non-magnetic masks.

ResMed, established in 1989, is Australia's largest medical device company, leading the sleep and respiratory solutions market in over 140 countries.

For 30 years, it has been offering sleep solutions for diagnosing and treating sleep disorders, and over 11.5 million patients worldwide are currently using ResMed products.