In June 2021, after discovering potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification.
We continue to work with independent partners to conduct extensive testing and analysis of results on affected devices, including biocompatibility evaluations.
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. Further testing related to the sleep therapy and ventilator devices remain ongoing.
Since the start of the test and research program, Philips Respironics has worked cooperatively with the FDA on the program and to publish regular test updates as agreed with the FDA.
New testing results documents can be found on this page as they become available.