FDA issued warning letters on ozone cleaners for CPAP machines

The FDA has issued warning letters to Leel Tech, Natures Pillow, Top Dog Direct, Adventure Innovations, and Shenzhen Moyeah for selling unapproved devices that claim to clean CPAP machines using ozone or ultraviolet light. The FDA has not authorized any CPAP cleaning devices, as ozone can worsen respiratory conditions and UV light can cause burns.

The warnings, sent in early August and posted online on August 28, instruct the companies to cease distribution of these products. This action follows Philips' 2021 recall of over 15 million CPAP devices, which linked ozone cleaners to issues with soundproofing foam. Philips has since stopped selling most of its respiratory devices in the U.S. and reached legal settlements. SoClean, another manufacturer, recalled its devices last year due to ozone concerns and is now being sued by Philips. The FDA recently cleared SoClean 3+ for reducing bacteria on CPAP accessories but advises using soap and water for cleaning.