August 19, 2021
The U.S. Food and Drug Administration (FDA) is recalling Philips Respironics ventilators, BiPAP, and CPAP machines 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.
Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. For details, see Philips Respironics recall notification (PDF). The FDA posted frequently asked questions about this recall.
For more information on the recall notification, contact your local Philips representative or visit Philips Respironics’ recall notification web page.