U.S. Food and Drug Administration warns of Philips Respironics BiPAP and CPAP Machines

The FDA is alerting consumers that Philips Respironics has recalled millions of BiPAP and CPAP machines due to potential health risks.   

The concern is polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to mitigate vibration and sound.  According to the manufacturer, the foam may break down and potentially enter the device’s air pathway, releasing debris that may be inhaled or swallowed by the device’s user.   

The affected machines were manufactured between 2009 and April 26, 2021.  For more information, see Philips’ Respironics recall notification.