MedWatch – The FDA Safety Information and Adverse Event Reporting Program

Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue – FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients, caregivers, and health care providers that Philips Respironics recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern, and it may also cause the machine to fail.

This recall is not associated with the PE-PUR foam issue for certain BiPAP machines recalled in June 2021. However, this recall does apply to some of the devices that were recalled in June 2021.

This safety communication provides:

• A link to the list of recalled devices, model numbers, and serial numbers.
• Recommendations for people who use these BiPAP machines, as well as their caregivers, and health care providers.
• Background on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems with the recalled BiPAP machines to the FDA.

 Questions?

If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com.

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