SoClean Recall Issued For CPAP Cleaners Due to Ozone Exposure Risks

The FDA warns that the level of ozone needed to properly clean a CPAP device is higher than what is considered safe for human exposure.

Following years of concerns about potential side effects, a recall has been issued for SoClean CPAP cleaning devices, which use high levels of ozone that may have negative health impacts on users.

The U.S. Food and Drug Administration (FDA) announced the SoClean recall on November 21, following the release of a field correction letter by the manufacturer. The company is not pulling the devices from the market, but instead publishing a new User Manual, as well as a hose and mask adapter to be used with the devices to prevent ozone-related illnesses.

SoClean, Inc. markets its devices to help sterilize and deodorize CPAP machines, which are used by millions of Americans to treat obstructive sleep apnea and help them breath while sleeping. To be effective at cleaning the CPAP machines, SoClean uses high levels of ozone gas, which has been linked to concerns about potential health risks for consumers.

Questions about the safety of SoClean emerged in the aftermath of a Philips CPAP recall announced in June 2021, which impacted millions of DreamStation, CPAP, BiPAP and mechanical ventilators sold with a polyester-based polyurethane (PE-PUR) sound abatement foam, which was prone to degrade and release toxic chemical and particles directly into the machine’s air pathways.

At the time of the recall, a number of statements were released that suggested the Philips CPAP foam degredation may be linked to ozone cleaning devices like SoClean, and those statements have been repeated as thousands of former users diagnosed with various types of cancer, lung damage and other injuries have come forward to file a Philips CPAP lawsuit.

SoClean Ozone Exposure Recall

According to SoClean, it has received 7,417 complaints about the CPAP cleaning devices, including 334 adverse event reports submitted to the FDA. Complaints included reports of mildew smells, excessive ozone smells, coughing, and problems with setting up and turning on the device.

Owners will receive a new version of the User Manual for SoClean2 and SoClean3 devices, which will include additional information about how to properly set up the devices, how to clean them, and how to detect unexpected levels of ozone. The manufacturer is also making a hose and mask adapter available to improve the safety of the devices.

The hose and adapter, which are being provided for free, are intended to prevent ozone emitted by SoClean from entering the CPAP unit. The recall also warns users that if the SoClean device is not turning on, or the smell of ozone is present, it is not set up properly.

All SoClean2 devices with UPC number 187293000860 are impacted by the recall, as well as SoClean3 devices with the same UPC number and a UDI number of (01)00858242007147.

FDA SoClean Safety Recommendations

The FDA has previously warned against the use of ozone or UV devices to clean CPAP units.

“Ozone, sometimes called ‘activated oxygen,’ is a gas that can be used to kill harmful bacteria,” the FDA states. “However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

The agency released a number of recommendations to help consumers avoid those unsafe levels of ozone exposure if they chose to continue using SoClean machines, calling for them to avoid using the devices without the hose and mask adapters, and to never connect SoClean equipment to a CPAP device while it is in use.

The FDA also called on users to follow the new SoClean cleaning instructions, and review the recall notice. Consumers with underlying lung diseases like asthma and chronic obstructive pulmonary disease (COPD) may be particularly sensitive to SoClean ozone exposure and should consult their healthcare provider before using the CPAP cleaning device, the agency cautions.

Consumers can contact SoClean Customer Care at 866-501-3705 or visit the website to receive a copy of the new user manual and the hose and mask adapter at no cost.

SoClean and Philips CPAP Lawsuits

However, in spite of the recall, SoClean already faces legal actions from consumers. Following the massive Philips CPAP recall issued in mid-2021, a series of SoClean class action lawsuits were filed later that year and early 2022, each raising allegations that consumers were not warned about the high levels of ozone used to sterilize and deodorize CPAP machines, indicating that SoClean marketed the toxic gas as “activated oxygen”.

On October 2021, SoClean sued Philips over the CPAP foam recall statements, claiming that its machine was being used as a scape goat for “inexcusable design flaws” in the sleep apnea machines, which placed a defective foam material directly in the devices’ air pathways.

Given common questions of fact and law raised in complaints filed throughout the federal court system, all SoClean lawsuits were centralized before U.S. District Judge Joy Flowers Conti, in the Western District of Pennsylvania, who was already presiding over all Philips CPAP lawsuits consolidated as part of a separate federal MDL.

As part of the coordinated pretrial proceedings before Judge Conti, it is expected that the Court will schedule a series of early “bellwether” trials to help the parties gauge how juries will respond to certain evidence and testimony that will be repeated throughout the claims.

While the outcome of these early trial dates will not have any binding impact on other claims, they are expected to influence the amounts of Philips CPAP settlements if the company wants to avoid the need for thousands of individual cases to go before juries in the coming years.