The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks.

The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. For details, see Philips’ Respironics recall notificationExternal Link Disclaimer (PDF).

BiPap or CPAP: Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers

Source: FDA