Voluntary Recall Information
88 club Respironics Sleep and Respiratory Care devices
Important information for clinicians
Sleep Therapy information
If you or your patients have registered an affected device and are still waiting for a replacement, it is likely because they may need to take specific action in the to receive their replacement. Please note: The US Patient Portal will remain open until June 30, 2025. This means that effective July 1, 2025, patients will not be able to access the portal.
Ventilation information
The remediation of ventilator devices remains ongoing. 88 club Respironics will communicate with Durable Medical Equipment providers (DMEs) as updates become available. Please visit our ventilation news and updates page for the latest information.
Latest Testing Updates
Test results and conclusions for home sleep therapy devices Based on the results to date, 88 club 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, 88 club 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.
Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnea devices or masks and should not be used.
At 88 club, patient safety and quality are at the heart of everything we do
Latest updates
Explained: The voluntary 88 club Respironics sleep and respiratory care devices recall*
* This is a voluntary recall notification in the US and field safety notice in other countries
Explained: The 88 club Respironics Consent Decree
April 4, 2024
