The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

The FDA remains steadfast in our commitment that patients impacted by the June 2021 recall of certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines deserve relief. While this matter is ongoing, the agency continues to monitor the company’s recall progress and share new information with device users, patient care facilities, and other stakeholders. The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.

In June 2021, the FDA alertedExternal Link Disclaimer people who use certain Philips ventilators, BiPAP machines, and CPAP machines because of potential health risks – impacting 15 million devices worldwide. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The alert was based on problems reportedly associated with the PE-PUR foam breakdown that could potentially result in serious injury and may require medical intervention to prevent permanent injury.