SoClean Class Action Lawsuit Filed Over Health Risks From CPAP Sanitizing Products

A class action lawsuit has been filed against the makers of SoClean, alleging that popular devices used to clean and sanitize CPAP, BiPAP and mechanical ventilation machines release ozone gases at dangerously high levels.

The complaint (PDF) was filed by Anthony Sakalarios on September 3 in the U.S. District Court for the Southern District of Mississippi, indicating false and misleading claims have been made about the SoClean 2 CPAP Sanitizing Machine, SoClean 2 Go CPAP Sanitizing machine and related products sold in recent years.

SoClean devices work by generating ozone to sterilize and deodorize CPAP breathing machines, which are used treat sleep apnea. However, the lawsuit notes that to be effective at sanitizing the devices, SoClean devices must emit levels of ozone that are higher than can be safely tolerated by humans or animals.

Sakalarios indicates he, and other similarly situated owners the SoClean machines, were misled by false advertising, which claimed the devices used “activated oxygen,” instead of telling consumers that it releases dangerous levels of ozone that exceed acceptable federal safety standards. In the company’s advertisements, it never mentions the use of ozone, and in some cases denies the devices are emitting ozone when asked directly, according to the complaint.

In fact, the advertisements claim the devices release no “harsh chemicals” at all, and Sakalarios’ lawsuit maintains that ozone is, in fact, considered a harsh chemical.

“The foregoing false claims deceive consumers into believing that the SoClean devices do not generate ozone, do not release ozone into the atmosphere, and are safe, healthy, and suitable for use in consumer’s bedrooms,” the lawsuit states. “SoClean’s falsehoods have allowed it to command a ninety-percent share of the market for CPAP sanitizing/sterilization devices.”

In late February, the FDA issued safety communication, indicating patients and healthcare professionals should not use what the agency considers illegally marketed ozone gas or ultraviolet (UV) light cleaning devices to disinfect or sanitize CPAP machines. The warning came following nearly a dozen reports of patients suffering respiratory complications.

Individuals reportedly experienced coughing, difficulty breathing, nasal irritation, headaches and asthma attacks after using these types of devices.

Just a few months later, in June, a massive Philips CPAP machine recall was issued, following the discovery that a polyester-based polyurethane (PE-PUR) sound abatement foam inside the machines may degrade and release toxic particles directly into the air pathways.

Philips has suggested that use of SoClean and other similar cleaning devices involving ozone and UV light may exacerbate the foam’s degradation, which could worsen respiratory side effects for users of the CPAP machines. The company now faces a mounting number of CPAP machine lawsuits and class action claims, indicating that users have been diagnosed with cancer, severe respiratory problems and other health complications.

Sakalarios’ lawsuit seeks class action certification for citizens of Mississippi who purchased SoClean devices to clean and sanitize their CPAP, BiPAP or mechanical ventilation breathing machines. He presents claims of breach of warranty, fraudulent misrepresentation, fraud by omission, negligent misrepresentation, unjust enrichment, failure to warn, and calls for the manufacturer to provide medical monitoring for the devices’ users.

28 Comments

  • LindaOctober 13, 2021 at 6:34 pm

    I too have had issues as I am an asthmatic and have been using soclean for 2 years now. I thought my asthma was just getting worse. Of course I have stopped. Any lawsuits for Florida out there? Thanks.

  • DonOctober 13, 2021 at 2:03 pm

    I purchased my SoClean a few years ago but only used it for a few months, I noticed that the water in my reservoir contained a growth after I'd use the cleaner. I didn't like the ozone smell either, overall I don't think this was the best nor safest way to keep the cpap clean. I don't know what this has done to my lungs.

  • PauloOctober 12, 2021 at 7:14 pm

    Please let me know if there's a lawsuit in HI. I have been using SoClean for over 5 years and not sure if it is causing me bad allergies, difficult breathing and stomach pains some mornings. Guess I will not be using this product anymore!

  • MichaelOctober 12, 2021 at 4:09 pm

    I use a ResMed cpap with a SoClean. I was awoken the other night by a taste of a chemical in my mouth, throat and upper chest. It took about 30 minutes for the pain, SOB and taste to subside. Called my cpap supplier but they where of no help. Looked on line to find out about the issues with SoClean. Hopefully this feeling in my chest will go away after I stop using the ozone. I have used SoCle[Show More]I use a ResMed cpap with a SoClean. I was awoken the other night by a taste of a chemical in my mouth, throat and upper chest. It took about 30 minutes for the pain, SOB and taste to subside. Called my cpap supplier but they where of no help. Looked on line to find out about the issues with SoClean. Hopefully this feeling in my chest will go away after I stop using the ozone. I have used SoClean for at least 4 years.

  • BillieOctober 11, 2021 at 1:19 pm

    i have developed chronic hoarseness and have to see a vocal cord specialist

  • GailOctober 10, 2021 at 8:54 pm

    I thank God I don't seem to have any health problems from my SoClean. The only loss I have is the $300 purchase price -- would love to recover that if NJ has a class action brewing....

  • ChristineOctober 10, 2021 at 5:43 am

    What about NC? I bought a SoClean late last year (2020), but only set it up this week (Oct 2021). Everything seemed to be fine; the green light on the unit showed up, which indicated it supposedly had worked properly and my cpap was ready to be used. I ran my cpap for 2 minutes before putting the mask on, as instructed. However, after putting my mask on, I still smelled the ozone so i took the mas[Show More]What about NC? I bought a SoClean late last year (2020), but only set it up this week (Oct 2021). Everything seemed to be fine; the green light on the unit showed up, which indicated it supposedly had worked properly and my cpap was ready to be used. I ran my cpap for 2 minutes before putting the mask on, as instructed. However, after putting my mask on, I still smelled the ozone so i took the mask back off for another few minutes while keeping the cpap running. 15 min later, I can still smell ozone from my cpap/mask, so I think I will be disconnecting the SoClean and not using my cpap this evening, just to be sure. Not feeling safe.

  • ChristopherOctober 10, 2021 at 3:48 am

    I have a so clean and tld my wife it smells funny after I clean. Have done this for serveral years now. I just found out my Dreamstation is on recall list. I have had respiratory problems for several years now. Nothing I tried cleared it up. I also now suffer from stage 4 Kidney failure, and have had several bouts of Heart failure. Just realized the smell and issue with OZone. They are defi[Show More]I have a so clean and tld my wife it smells funny after I clean. Have done this for serveral years now. I just found out my Dreamstation is on recall list. I have had respiratory problems for several years now. Nothing I tried cleared it up. I also now suffer from stage 4 Kidney failure, and have had several bouts of Heart failure. Just realized the smell and issue with OZone. They are definitely using false advertising to sell the SoClean. May start my own lawsuit in Indiana

  • AnneOctober 9, 2021 at 5:07 pm

    I have been using my so clean for 2 yrs now and my asthma has gotten much worse and now having other breathing problems. I feel I was mislead and now I am suffering for something I believed to be true. Missouri

  • JeriOctober 8, 2021 at 4:24 pm

    I have a so clean 2 I wake up every morning with head aches and sinus problems.

  • SylvesterOctober 8, 2021 at 12:31 am

    I've noticed a fowl oder coming from soclean machine

  • JimOctober 7, 2021 at 2:53 pm

    I wakeup every day with sinus like headaches whether I use the so lean or not with my Phillips cpap.

  • KARENOctober 6, 2021 at 12:03 am

    Is there a class action in CA? I bought mine this last year and am concerned and afraid to use it now!

  • WaltOctober 4, 2021 at 9:12 pm

    I have been using the So-Clean for over 5 years. I would wake up every morning with severe nasal congestion that would take over 1-2 hours to go away.I would cough up mucus all day.These symptoms got much better after I stopped using the So-Clean. I am concerned about long-term effects from using this device.

  • KasandraOctober 4, 2021 at 5:07 pm

    Been using the so-clean machine for a little over a year. Started having trouble breathing and gasping for air when using my CPAP machine. Need to know if other states are going to be included in this class action lawsuit. I did get a new machine due to the re-call, but you can't even hook it up the So-clean with the new machines. Has anyone been successful with at least getting their money back [Show More]Been using the so-clean machine for a little over a year. Started having trouble breathing and gasping for air when using my CPAP machine. Need to know if other states are going to be included in this class action lawsuit. I did get a new machine due to the re-call, but you can't even hook it up the So-clean with the new machines. Has anyone been successful with at least getting their money back for a machine that is un-usable?

  • AlanOctober 4, 2021 at 12:49 am

    Cant trust anyone. Look at our own government after September 11. All officials said the air was safe around the area of the Towers. Yet people and responders later fell ill. Money and power rules and people are disposable it would appear.

  • NickyOctober 1, 2021 at 8:45 pm

    Looking for class action lawsuit against Soclean been having eye and respiratory problems didn’t know what could be causing this also used dream station cpap. Please help

  • StaceyOctober 1, 2021 at 8:15 pm

    Please advise if there is a lawsuit in Pa. I have developed a chronic cough since using So Clean and can't afford to just write the money it cost me off.

  • WayneOctober 1, 2021 at 6:01 pm

    Geez, I have a Philips on the recall list, and, I have a So Clean. Double-whammy. Maryland

  • CaroleSeptember 29, 2021 at 4:22 pm

    My husband purchased and used the So Clean Machine until he was informed it can be hazardous to his health. How does he join a class-action lawsuit in Pennsylvania? Thank you.

  • StephenSeptember 29, 2021 at 2:23 am

    I have Socleam machine for several years. First Dreamstatin I used it on just quit working. It emits a strong unpleasant order. I obtained a second Dreamstation at my expense but just stopped using it after reading of cancer dangers.

  • RobertSeptember 27, 2021 at 4:48 pm

    Is there a class action suit in Pennsylvania? I’ve noticed on many occasions the strong odor of Ozone in my bedroom. Both my wife and I have our own SoClean 2 machines and put them both on in the morning. I also have problems breathing at night and can also smell ozone in my mask at night. Sometimes I feel I can not breath using my cpap machine. I will be seeing my pulmonologist about this conditi[Show More]Is there a class action suit in Pennsylvania? I’ve noticed on many occasions the strong odor of Ozone in my bedroom. Both my wife and I have our own SoClean 2 machines and put them both on in the morning. I also have problems breathing at night and can also smell ozone in my mask at night. Sometimes I feel I can not breath using my cpap machine. I will be seeing my pulmonologist about this condition.

  • RebeccaSeptember 27, 2021 at 4:45 pm

    I started wi a c pap n use if so clean for my device. Since then my numbers have increased an now have moved from c pap to by pap due to my air need n worsening w my lungs

  • ValerieSeptember 25, 2021 at 7:56 pm

    I just got for so clean machines for for my adult children in the month of April 2021 I called so clean to return The machines only one of my children use one he noticed that he was getting headaches and the smell is horrible in his house I told him not to use it anymore until I get a hold of so clean and they try their hardest assured me I don’t feel safe for anyone to use this product –I talk[Show More]I just got for so clean machines for for my adult children in the month of April 2021 I called so clean to return The machines only one of my children use one he noticed that he was getting headaches and the smell is horrible in his house I told him not to use it anymore until I get a hold of so clean and they try their hardest assured me I don’t feel safe for anyone to use this product –I talked to Vicky F. She has a script to follow I’m sure I’m not blaming her I just blame the company for not sending me my labels to return these items I cannot use !!!!! They sure give a good sale pitch but if you really believe in your product and your product is safe you always give 100% moneyback guarantee not 30 days obviously they’re not backing up their product !!!!

  • DavidSeptember 24, 2021 at 11:02 pm

    I have been using a Soclean for two years now and recently I’ve been having breathing problems and shortness of breath. Been to several doctors but with no diagnosis.

  • BrenfaSeptember 23, 2021 at 10:17 pm

    My husband has parkinsons and has been using so ckean for his cpap machine. He has has developed a terrible time breathing at night. The breathing problems effect him more at night after getting into bed. Why weren't physicians notified in order to give guidance to their patients. I would have disconnected both cpap and the so clean. I am making an appmt for my husband to find out why his bt[Show More]My husband has parkinsons and has been using so ckean for his cpap machine. He has has developed a terrible time breathing at night. The breathing problems effect him more at night after getting into bed. Why weren't physicians notified in order to give guidance to their patients. I would have disconnected both cpap and the so clean. I am making an appmt for my husband to find out why his bteathing has become so bad.

  • JerrySeptember 20, 2021 at 11:25 pm

    My wife and myself have socleans. We believe they are the cause of lung problems we each have suffered.

  • BonnieSeptember 16, 2021 at 4:44 pm

    Are there any Class Action Lawsuits against Soclean in any other state other Mississippi?

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