Compass Health Recalls Full Face Mask Cushion Devices

Compass Health Brands issued a recall of its Probasics brand continuous positive airway pressure (CPAP) full face masks, used for the treatment of obstructive sleep apnea.

The product was pulled because the company implemented a design change that made the mask’s cushion seal replacement part and accompanying elbow replacement part incompatible with the mask.

The FDA identified the recall as Class I, meaning that use of the device could cause injury or death. In total, 742 CPAP full face masks were recalled nationwide.