FDA’s Warning on SoClean and Ozone CPAP Cleaning Devices

If you’re a CPAP user, you’ve likely heard of devices like SoClean that use ozone gas to treat CPAP equipment. However, the FDA has issued warnings about potential risks associated with ozone-based CPAP cleaners. These devices, including SoClean2 and SoClean3, are not authorized by the FDA as cleaning devices for CPAP machines and accessories.

This article explains what the FDA has said about ozone devices, the risks associated with them, and why proper washing remains the most reliable way to clean CPAP equipment. We’ll also introduce the CSpring RediClean®, an automated washing system designed to simplify CPAP equipment cleaning.

Why the FDA Warns About Ozone CPAP Devices

In November 2023, the FDA issued a safety communication regarding ozone-based CPAP cleaners, including the SoClean2 and SoClean3, which were part of a voluntary recall. The recall included updated instructions and adapters intended to reduce ozone exposure and prevent damage to CPAP equipment.

The FDA also noted that ozone devices do not remove physical debris such as oils, dust, or mineral buildup from CPAP equipment. Over time, these materials can accumulate on masks, hoses, and humidifier chambers, which is why regular washing remains essential for CPAP maintenance.

Potential Concerns with Ozone Exposure

One of the FDA’s primary concerns with ozone devices is ozone exposure.

Ozone, also known as activated oxygen, is classified as a reactive gas by regulatory agencies including the FDA and EPA. Exposure to ozone may:

• Irritate the lungs
• Aggravate respiratory conditions such as asthma or COPD
• Cause throat irritation or coughing

Even after treatment cycles, ozone gas may remain inside hoses or chambers if equipment is not properly ventilated.

For CPAP users—many of whom already manage respiratory conditions—this is an important consideration.

The Best Way to Clean CPAP Equipment

The most widely recommended method for cleaning CPAP equipment is regular washing with mild soap and water.

Unlike ozone devices, washing physically removes oils, dust, residue, and mineral deposits from CPAP masks, hoses, and humidifier chambers.

How to Properly Clean CPAP Equipment

Daily

Rinse the CPAP mask cushion to remove oils from skin contact.

Weekly

• Wash tubing, mask, and water chamber with warm, soapy water
• Rinse thoroughly to remove soap residue
• Allow all components to air dry completely

Monthly

Replace disposable filters and inspect equipment for wear or damage.

Routine cleaning helps keep CPAP equipment functioning properly and helps maintain a comfortable therapy experience.

A More Convenient Way to Wash CPAP Equipment

For CPAP users who prefer not to wash equipment by hand, automated washing systems provide an alternative.

The CSpring RediClean® is designed to simplify the process of cleaning CPAP accessories.

Instead of manual soaking and rinsing, the RediClean system uses:

• Pressurized water jets
• Food-grade citric acid cleaning solution
• Steam-assisted washing
• HEPA-filtered hot air drying

This process helps wash CPAP hoses, masks, headgear, and humidifier chambers while eliminating the need for manual scrubbing.

Why Many CPAP Users Choose Automated Cleaning

The RediClean system is designed to help simplify CPAP maintenance by:

• Washing CPAP accessories automatically
• Reaching areas inside hoses that are difficult to clean manually
• Reducing the time required for regular CPAP maintenance
• Drying accessories with filtered hot air

For many users, this makes it easier to maintain a consistent CPAP cleaning routine.

Why CPAP Equipment Maintenance Matters

Keeping CPAP equipment clean helps maintain performance and comfort during sleep therapy.

When equipment is not cleaned regularly, users may experience:

• Odors from accumulated oils or residue
• Mineral buildup in humidifier chambers
• Reduced mask comfort
• Shortened lifespan of CPAP accessories

Regular washing helps maintain equipment condition and improve the overall CPAP experience.

A Simpler Approach to CPAP Cleaning

The FDA’s warnings about ozone devices highlight the importance of safe and effective CPAP maintenance practices.

Regular washing remains the most reliable method for cleaning CPAP equipment. For users seeking a more convenient approach, automated systems like CSpring RediClean® provide a way to simplify the cleaning process for CPAP hoses, masks, and humidifier chambers.