The U.S. Food and Drug Administration (FDA) has updated a safety communication on certain Philips Respironics ventilators, BiPAP machines, and CPAP machines that were recalled due to potential health risks.

In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines because of potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.

From April 2021, through April 30, 2022, the FDA received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

The FDA has posted recommendations for patients and providers related to the recall.

U.S. Food and Drug Administration (FDA). Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. May 19, 2022. Available at: click here. Accessed May 23, 2022.