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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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

Today, the U.S. Food and Drug Administration (FDA) is providing the latest information about medical device reports (MDRs) received from May 1 to July 31, 2022, that are associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the June 2021 recall.

The FDA will continue to update the public about the status of the Philips Respironics June 2021 recall.

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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.