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Voluntary Recall of SoClean Equipment intended for use with CPAP Devices and Accessories: FDA Safety Communication

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to provide additional information about the voluntary recall of SoClean2 and SoClean3 equipment used to clean, sanitize or disinfect CPAP devices and accessories.

This SoClean device recall includes new instructions for device use, including the importance of using a hose and mask adapter provided by the company. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of SoClean2 or SoClean3 equipment.

This safety communication provides:

• Important recommendations for consumers.
• Background on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems to the FDA.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education.