The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. These potential adverse events can occur in people who use the masks, or in people near a person using the mask. The recalled masks have magnets (placements shown by black circles in the picture below) and can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern.

UPDATE: In September 2022, the FDA classified this recall as a Class I recall, the most serious type of recall.

Magnet blocks recalled