Philips Respironics has voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (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. On June 30, 2021, the FDA issued a safety communication: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks.
The FDA has heard from many of the people using these affected devices. We recognize the seriousness and scope of their concerns. The FDA is continuing to work with Philips Respironics to assure that the company provides sufficient evidence to show the safety and effectiveness of its proposed actions to correct the product defect.
This page provides answers to frequently asked questions related to this recall.
Have you or a loved one suffered an injury or illness from this device? Contact Warren & Griffin for a free consultation, and our experts will take good care of you.