The SoClean lawsuit — a consolidated multidistrict litigation over the company’s ozone-based CPAP cleaning devices — ended on March 10, 2026, when a stipulation of dismissal with prejudice was filed in the Western District of Pennsylvania. The named consumer plaintiffs settled their individual claims against SoClean in October 2024, and the remaining cross-claims between SoClean and Philips were resolved before a scheduled July 2025 trial. Financial terms of the settlement were not publicly disclosed.
What Consumers Accused SoClean Of
Roughly two dozen class actions were filed by people who bought SoClean devices to sanitize their CPAP machines. The core allegation was that SoClean marketed the products as safe while concealing that they emit ozone at concentrations around 30 parts per million, hundreds of times above the FDA’s 0.05 ppm safety limit for enclosed spaces.1About Lawsuits. SoClean Recall Ozone Exposure Risks
Plaintiffs said the devices’ internal filters, which were supposed to convert ozone back to breathable oxygen, did not work as advertised, and that the machines lacked an automatic purge cycle to clear residual ozone from CPAP tubing before the next use. Reported symptoms included coughing, throat and eye irritation, shortness of breath, reduced lung function, and worsened asthma. The FDA itself has stated that ozone concentrations needed to effectively kill bacteria are “above levels considered safe for humans,” and preliminary lab testing by the agency found ozone-based CPAP cleaners generated ambient ozone above safe exposure limits.2FDA. Voluntary Recall of SoClean Equipment Intended for Use With CPAP Devices and Accessories Between 2017 and 2019, the FDA received 11 adverse event reports describing cough, breathing difficulty, nasal irritation, headaches, and asthma attacks linked to these products.3American Academy of Sleep Medicine. FDA Safety Communication on CPAP Cleaning Devices Using Ozone and Ultraviolet Light
How the Cases Were Consolidated
In February 2022, the Judicial Panel on Multidistrict Litigation consolidated the class actions into MDL No. 3021, In Re: SoClean, Inc., Marketing, Sales Practices and Products Liability Litigation, before U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania.4Mason LLP. Gary E. Mason Selected to Lead SoClean Litigation The panel placed the SoClean MDL alongside the separate Philips CPAP recall MDL (No. 3014) because both involved the same CPAP machines and overlapping questions about ozone’s role in device-related injuries.
The 2023 FDA Recall
On November 15, 2023, SoClean initiated a voluntary recall of its SoClean 2 and SoClean 3 models, which the FDA announced publicly on November 21 and classified as a “labeling design” recall.5FDA. SoClean Recall Details The devices were not pulled from the market. Instead, SoClean was required to provide updated user manuals and a complimentary hose and mask adapter meant to keep ozone out of the CPAP machine and its water reservoir. The FDA advised consumers not to run SoClean 2 or SoClean 3 devices without the adapter and told patients with lung or cardiovascular conditions to consult a doctor before use at all.2FDA. Voluntary Recall of SoClean Equipment Intended for Use With CPAP Devices and Accessories
Adverse event reports continued after the recall. A November 2023 report described a user experiencing constant lightheadedness, vertigo, shortness of breath, and difficulty speaking, attributed to ozone leaking into the bedroom from a poorly sealed device.6FDA MAUDE Database. SoClean 3 Adverse Event Report – MW5148542 A February 2025 report described nasal irritation, skin inflammation, fatigue, headaches, and a pulmonary condition that improved only after the manufacturer supplied an adapter bypassing the mask.7FDA MAUDE Database. SoClean 3 Adverse Event Report – MW5166148
SoClean and Philips: The Blame War
The consumer case became entangled with Philips Respironics’ June 2021 recall of millions of CPAP, BiPAP, and ventilator devices over a degrading polyurethane sound-abatement foam. Philips suggested that “unapproved cleaning methods, such as ozone” could speed the foam’s breakdown, and the FDA echoed that concern.8HME News. Makers of CPAP Cleaners Distance Themselves From Recall9American Academy of Sleep Medicine. FDA Safety Communication on Philips PAP Recall
SoClean sued Philips in the District of Massachusetts on October 12, 2021, seeking more than $200 million and alleging “deliberate misdirection” to divert attention from Philips’ foam placement in the air pathway. SoClean noted that nearly 80% of CPAP users used no cleaning device at all.10SoClean. SoClean Philips Lawsuit Philips countersued, alleging SoClean had known since 2015 that ozone was incompatible with Philips machines and could degrade the foam.11HME News. Philips Sues SoClean Again
After Philips reached a $1.075 billion personal injury settlement with CPAP users in its own MDL, it tried to make SoClean share the cost. In May 2024 Philips filed a third-party contribution complaint alleging that at least 15% of affected device users were confirmed SoClean customers.11HME News. Philips Sues SoClean Again Judge Conti dismissed a related Philips class action complaint without prejudice on December 18, 2024, calling the filing at an existing MDL docket “unprecedented” and questioning whether Philips had a “good faith basis” to serve as class representative for claims it had assigned to itself.12U.S. District Court, Western District of Pennsylvania. MDL No. 3021, Memorandum Opinion On February 25, 2025, the court dismissed Philips’ amended third-party contribution complaint on jurisdictional grounds, ruling it lacked subject-matter jurisdiction over contribution claims tied to settlement payments made to people who had never filed individual cases in the MDL.13Caselaw, FindLaw. In Re Philips Recalled CPAP Products Litigation
Settlement and Final Dismissal
On October 30, 2024, counsel for the consumer plaintiffs announced a settlement of the named plaintiffs’ individual claims against SoClean. The settlement did not resolve broader class claims, and financial terms were not made public.12U.S. District Court, Western District of Pennsylvania. MDL No. 3021, Memorandum Opinion What remained in the MDL was the business-to-business track: the cross-claims and counterclaims between Philips and SoClean.
Judge Conti set those remaining claims for trial in July 2025, stating that “no further continuances or delays will be permitted.”14About Lawsuits. Lawsuits Between Philips and SoClean Over CPAP Machine Problems to Be Trial Ready by July 2025 The trial did not happen. On March 10, 2026, a Stipulation of Dismissal with Prejudice was filed, ending the SoClean MDL.15U.S. District Court, Western District of Pennsylvania. MDL 3021 Docket Terms behind that dismissal have not been made public. A dismissal with prejudice typically bars refiling of the same claims.
Where SoClean and Its Devices Stand Now
The 2023 recall did not remove the SoClean 2 or SoClean 3 from the market. Owners are expected to use the provided hose and mask adapter and the updated instructions, and users with lung or cardiovascular conditions were told to consult a doctor before using the device at all.2FDA. Voluntary Recall of SoClean Equipment Intended for Use With CPAP Devices and Accessories
On August 12, 2024, the FDA granted De Novo clearance (DEN210037) for the SoClean 3+ Bacterial Reduction Device, creating a new Class II category called “respiratory accessory microbial reduction devices.”16FDA. SoClean 3+ De Novo Decision Summary The clearance is narrow. The SoClean 3+ is authorized only as an add-on used after regular cleaning to reduce bacteria on specific compatible CPAP masks and hoses, not as a standalone sanitizer for entire CPAP systems. At launch, safe use was established only with three specific ResMed accessories, and the labeling must state that the device does not replace manufacturer-recommended cleaning procedures. The FDA continues to state that it has not authorized any ozone or UV-light device for cleaning, disinfecting, or sanitizing CPAP machines and accessories more broadly, a distinction that separates the older recalled models from the narrowly cleared SoClean 3+.