Voluntary Recall Information

Important information for clinicians

We are fully committed to partnering with you to support your patients. 

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. Further testing related to the sleep therapy and ventilator devices remain ongoing. Following ongoing communications, Philips Respironics agreed in October 2023 to the FDA’s recommendations to implement additional testing on the sleep and respiratory care devices to supplement current test data. Philips Respironics is in discussions with the FDA on the details of further testing. 

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. The latest update can be found here.

As we continue to make progress on the remediation of CPAP, BiPAP and ventilator devices it is important that you are informed on the latest updates. We will continue to update our remediation progress page throughout the process.