Update on Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recall of June 2021

Today, the U.S. Food and Drug Administration (FDA) is providing updated information about medical device reports received from August 1 to October 31, 2022, 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.

Since April 2021, the FDA has received more than 90,000 medical device reports, including 260 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. The FDA will continue to update the public about the status of the Philips Respironics’ recall announced in June 2021. 

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Questions?

The FDA.gov website includes FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls to address questions about the recalls and provide additional resources with more information.  

For more information on the recall notification, contact your local Philips representative or visit Philips Respironics’ recall notification page.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.