Updates on Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls

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FDA - Center for Devices and Radiological Health

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Update on Philips Respironics June 2021 Recall

Today, the U.S. Food and Drug Administration (FDA) updated its safety communications and frequently asked questions about the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls on FDA.gov to provide the latest information about medical device reports associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam.

"The FDA remains committed to ensuring patients and providers have timely information about the recalled devices. In addition to our recent notice to the firm, we are continuing to closely monitor the reports and the risk posed by the foam. Our recommendations to patients and providers remain unchanged at this time and we will continue to provide updates as we gather and analyze additional information, including any further actions related to this recall."
— Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

We will continue to update the public about the status of this recall and share more information when it becomes available.

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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.