Voluntary Recall Information

We know how important it is to feel confident that you are cleaning your device properly.

For detailed information about caring for your replacement device, please refer to the device's User Manual and Accessory Cleaning and Inspection Instructions. It is important that you use only the cleaning methods approved for your device, as unapproved cleaning methods such as ozone may contribute to foam degradation.  Please note that both ozone and UV light cleaning products (including the Philips UV Light Sanitizer Box) are not currently approved cleaning methods for our devices or masks and do not remediate the current recall.

 

Please also refer to the FDA safety communication issued on February 27, 2020 titled “Ozone and UV light: Potential Risks associated with the use of ozone and ultraviolet (UV) light for cleaning CPAP machines and accessories.”   Continue reading below for a few key points stated in the article:

 

• “Follow the CPAP manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. If you cannot find the owner’s manual or instructions, or have questions, contact the CPAP device or accessory manufacturer.  You also can contact your health care provider with any questions.”
• “Be aware that the FDA has not evaluated the safety and effectiveness of ozone gas or UV light products claiming to clean, sanitize or disinfect CPAP machines and accessories in the home or healthcare setting.”