Explained: The voluntary Philips Respironics sleep and respiratory care devices recall*

What products were recalled?

In June 2021, Philips Respironics initiated a voluntary recall notification for certain CPAP and BiPAP sleep therapy devices and mechanical ventilators to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. You can find the full list of affected devices here and the full notification is available to read here.

Why was the PE-PUR foam used originally?

Philips Respironics used PE-PUR sound abatement foam to minimize sound and vibration in certain CPAP, BiPAP and ventilator devices. These medical devices were designed to meet all relevant standards at the time of development and launch.

What’s the status of this recall?

Globally, we have remediated more than 99% of actionable** sleep therapy device registrations to date. We continue to prioritize the remediation of mechanical ventilators. Those efforts are ongoing in coordination with the relevant competent authorities.

When was it discovered that there were potential risks that ultimately led to the recall*?

In the years prior to 2021, complaints related to possible PE-PUR foam degradation were investigated, evaluated, and addressed by Philips Respironics primarily on a case-by-case basis. When Philips became aware of the issue and its potential significance in early 2021, Philips and Philips Respironics took actions that led to the voluntary recall* in June 2021.

Although Philips and Philips Respironics only had a limited amount of information regarding the potential health risks, the recall decision was made in an abundance of caution, after careful consideration of a reasonable worst-case scenario, rather than deferring the recall decision to conduct more definitive testing. That additional testing occurred after the recall announcement, as discussed below.

Has Philips Respironics conducted further testing and analysis on the affected devices?

Together with five independent, certified testing laboratories and third-party experts, Philips Respironics has conducted extensive testing since June 2021. Based on the results to date, Philips Respironics and the third-party experts concluded that use of the sleep therapy devices is not expected to result in appreciable harm to health in patients.

* This is a voluntary recall notification in the US and field safety notice in other countries

** Actionable registrations are those that contain the necessary information needed to complete the remediation and are not awaiting further information.