Philips' Recalls Not Associated with the Foam Issue.

What to Do with Your Device: Cleaners, Filters, Foam, Returns.

How to Know if You Should Stop Using Your Device.

How to Tell if Your Device Has Been Recalled and What to Do Next.

The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs.

The FDA recognizes that many patients have questions about what this information means for the status of their devices. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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 polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. UPDATE - June 2, 2023: The FDA safety communication was updated to provide information about medical device reports (MDRs) the FDA received from January 1, 2023, to March 31, 2023, that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.

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