ResMed's CPAP Warning Is Now a Class I Recall

ResMed’s voluntary recall of some of its CPAP mask magnets has now been labeled as Class I by FDA. The agency announced the classification late last week.

In November, ResMed began recalling some models of the masks because of possible interference with certain medical devices and implants which might disrupt their function or position.

While the existing label advises keeping magnets 2 inches away from affected medical devices, it doesn't list all the specific ones that could be affected by the masks' magnets. ResMed is recalling these masks to update the labels, and add more warnings and information to guide patients and healthcare professionals on safe usage when using masks with magnets.

The recall covers model numbers AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30 and AirFit F30i. There have been six reported injuries but there have been no reports of death, according to FDA’s website.

ResMed’s rival in the space, Philips, has been embroiled in recalls for the past few years now.  The latest chapter in the saga is a scathing report from ProPublica and the Pittsburgh Post-Gazette on the handling of its respiratory device recall.