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

A lawsuit against SoClean manufacturer alleges CPAP sanitizing machines release harmful levels of ozone.

Irvin Jackson

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A class action lawsuit has been filed over potential SoClean health risks, alleging that popular devices used to clean and sanitize CPAP, BiPAP and mechanical ventilation machines release ozone gasses 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 to treat sleep apnea. However, the SoClean lawsuit notes that to be effective at sanitizing the devices, the devices must emit levels of ozone that are higher than can be safely tolerated by humans or animals.

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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 released by SoClean machines 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.

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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 CPAP machine users.

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.

Tags: Cancer, Chemicals, Class Action Lawsuit, CPAP, CPAP Recall, False Advertising, Ozone, Respiratory, SoClean

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266 Comments

  1. Jeff

    I have used a soclean2 for over a year and wake up everyday dizzy and suffer from congestion also. I am now wondering if its due to the soclean2 and my cpap.

  2. Dallas

    I went to my doctor & the so clean machine was destroying the inner part of the CPAP MACHINE & was throwing out little black rubbery things a like a poppy seed but larger & were in my mask & bed. My doctor told me to quit using it.

  3. Barry

    Add me to the SoClean list. Been waking up with headaches, sinus drip, dry mouth, etc. Live in FL.

  4. Marianne

    I bought one of these several months ago. After having my CPAP recalibrated, I was told about the SoClean law suit because of the different health risk and why. I immediately stopped using it.

    I would like to be refunded my money, also. If this was sold under false advertisement and a health risk, there should be no excuse for refunding my money. I bought this product in good faith.

  5. Terry

    I’ve been using my So Clean 2 every day for a couple of years. I’ve been sick twice now in two months with Hard Coughing and Serious Nasal problems along with a sore throat. Today will be the last time I ever use it again. I pray that my lungs are not permanently damaged.

  6. Nancy

    Yes, my daughter purchased a SoClean machine for me and I am congested every morning. My doctor told me to stop using the machine. Can we get our money back! Is there a class action suit I can join?

  7. Roy

    After reading the comments I notice a lot of similarities to my own experiences with my Soclean machine that I’ve been using on and off for my Resumed CPAP. I actually asked my Pulmonary doctor did I have to go on oxygen because of my difficulty breathing?

  8. Ruby

    I have a so clean machine and I quit using it because on the awful smell that filled the room while it was cleaning. Also I woke up with headaches and sick stomach. Want to know if I can be refunded the cost of it.

  9. Richard

    Statement below, not going to repeat.

  10. Molly

    I do smell the ozone from the machine and have noticed an intolerance and inability to wear my CPAP, which only started as soon as I got the SoClean. I’ve had a CPAP for over a decade without an issue, but ever since my mother purchased me a SoClean as a gift and I starting using it I’ve not been able to wear my CPAP for an entire eight hours of sleep and the foam on my mask no longer securely fits against my face as a result my mask leaks. I wonder if the SoClean is breaking down the foam structure of my mask. I now truly wonder if the SoClean is the issue for all my new CPAP use issues?

  11. Alan

    Ever since I began using the SoClean 2 months ago the instances of sinus infections have quadrupled, Asthma attacks have numerically exceeded previous years and I wake up every morning, and often in the night with a lot of thick mucus in my bronchial tubes, a burning scratchy irritation in lungs, a clear drainage from my nostrils and a cough that is often uncontrollable and racks my whole upper body. I have had the SoClean 2 for right at one year. Is there any recourse I have? I would sure like to find a machine without the risks but I would like even better to get rid of these pulmonary problems. Help!

  12. Rondale

    I purchased a Soclean in May 2019, one for my Son July 2019 and one for my sister in August 2021. My sister told me she could not use it because the smell was to strong and made her feel uncomfortable. My son stopped using his because he is on chemo-therapy. I had been getting a lot of coughing and respiratory infections and started to read some comments online about the Soclean. I stopped using it toward the end of 2021 and have had no problems since.

  13. David

    I’ve been on a CPap since September 2021. I purchased a Soclean about 6 months ago, Since I started using the SoClean I have developed a persistent cough that sometimes takes my breath. I also have a serious problem with sinus drainage. Sometimes it’s like turning on a water faucet. I didn’t know until today, when I was ordering a new hose and water chamber from the company that my Cpap came from about all the issues others were having with their cleaning machines. The rep told me about the law suits that have been filed against Soclean. We couldn’t figure what was causing the cough and sinus issues. I think we got our answer today.

  14. Wayne

    Every since I have been using my So Clean, I have had nasal drip, constantly, coughing, etc. It just never occurred to me, it was the machine. I have been taking antihistimens every day, but doesn’t seem to help.

  15. Mark

    Put me on the list, big expensive paper weight.

  16. Ray

    I was very happy with my SoClean until my bi-pap machine was recalled. The smell of ozone is no different than what you smell after a lightning storm and if you run your ?-pap for a few minutes before wearing your mask, it’s hardly noticeable. The problem is how to deal with Phillips and SoClean fighting about who is responsible. We have a lot of money tied up in these devices and now we may be stuck with nothing.

  17. Phyllis

    I have been having issues for 2 plus years with sinus infections , coughing , trouble sleeping because of breathing problems. Did not know anything about the law suit until I found it by accident.

  18. Janean

    I have two homes, so I purchased a SoClean for each location. I have had a terrible cough for the past 2-3 years and I just found out about issue with the SoClean being used with the CPAP! This is outrageous! There should be a class action lawsuit for anyone who has purchased a SoClean! They are so expensive on top of the fact that they are dangerous to your health!

  19. James

    I had no idea that there was a problem with my SoClean machine that might be causing my excessive coughing. When I saw my pulmonary dr., she found out I was using a SoClean and she said stop immediately. My cardiologist has checked me out well to make sure the coughing wasn’t coming from congestive heart failure, and he found no signs. I had been coughing really bad for about a year (very productive) with indications of other problems. I need to know what happens with these expensive SoClean machines, I certainly don’t want anyone else to have the same problem I have had.

  20. Eugene

    I have used the So Clean machine since they first came out. I have had nights when I woke-up short of breath. Every day when I get up, my nose and mouth is extremely dry. In the morning I have excessive nasal drainage, requiring me to repeatedly blow my nose for the first hour.

  21. WE

    I was gifted a new soclean2 cepap cleaning machine a couple of years ago and have developed severe productive cough nite and day plus my dog that slept during daytime in my bed room has passed with respotory problems. Please help?

  22. Lisa

    I used a CPAP machine every night for a year and a half. Cleaned it extremely well every day. I had issues with coughing,dry nose and mouth and sore throat. I quit using my machine when it was recalled. On March 23,2022 and for no appointment reason (all test on my heart show no issues) I woke up having a heart attack. Recently I was advised by the cardiologist and the pulmonary Dr to go back on the CPAP machine. I don’t plan on doing that. If a medical doctor can explain to me without any doubt what caused my heart attack and the use of the CPAP machine is ruled out one hundred percent the and only then will I consider it. My cardiologist said that I stay extremely tired due to the fact that I quit using the CPAP machine.I bet I wouldn’t stay tired if I use it again and die of cancer or breathing issues. As of stopping using the CPAP machine I have had no dry mouth or nose, no sore throat or cough unless I have a cold or allergies.So to using the CPAP machine or the Soclean I will pass.

  23. Stan

    Ive had breathing problems and sinus problems ever since I started using the SoClean machine to clean my CPAP.

  24. iris

    I have not experienced any health issues to date that I can say started with my So Clean 2, however, I dont know either if something has started and has not manifested. How can one get a refund or ther money back from purchasing one of these machines?

  25. Becky

    I have chest ache/pressure, soreness in my lungs when I breathe. Hey So Clean, come and try my machine for a few years and see what it feels like. I want my money for the machine back, and pain and suffering. …or I will settle for my health back the way it was.

  26. Rolando

    I bought and have been using the SoClean2 since February, 2020. I have gradually been having more respiratory issues. Also read that it may have affected the ResMed cpap that I use. Should I replace the ResMed cpap I presently use that may be damaged or wait for your advice.
    SoClean is washing their hands with all of this and blaming Phillips for spreading lies.
    Please advice and add me to the class action suit

  27. Tony

    I own the soclean2 cpap cleaning and I need to help with with what steps to take for the law suit and to get my money back that I pay for the machine. I have 2 cpap machines my self and my daughter has one. Also she has Asthma. Please help

  28. Marie

    I’ve used a ResMed machine for a few years. I stopped using it because it made me have respiratory problems such as constant sneezing, running nose, headaches. Then I got the notice of a recall how do I make a claim to manufacturer for help.

  29. Edwin

    I have been using a SoClean since 2017. Both my wife and I have been having increasingly worse respiratory issues, headaches sinus problems.
    I would like to join the class action.
    ⁹

  30. Randal

    I want my money back from my SoClean machine. Shame on a company that sells a machine to a consumer knowing that its going to harm us and going to make us sick.

  31. Ray

    I have been using a CPAP machine for 9-10 years. first started out with the Phillips Dream station and switched to the RESMED Airsence P10 several years ago. I purchased a So-Clean couple years back and will now disconnect after reading these comments.

  32. Randy

    I have used Res- med CPAP machine for years my wife cleaned the mask and reservoir daily. A few years ago we scraped enough money together to buy it so clean machine so that she would not have to do the mask reservoir every day like shit done throughout the years. During the time of using so clean machine I had Mersa pneumonia twice was hospitalized both times. Developed a cough that I’ve had now for years and begin to have a fib heart trouble. Was trying to get an adapter for the new res-med machine I got in just in May after my last bout With Mercer
    pneumonia at the end of April of this year, When trying to get the adapter I read about the lawsuit against so- clean. I have not been using the so clean machine since May my breathing has gotten better oxygen level has continue to climb since that time. I would like to join in this lawsuit, please send me the information on how to join

  33. John

    I have been using so clean over 8 years. I have chronic sinus and respiratory issues I now fear just got worse over time by using this machine all this time. What to do now??

  34. John

    I have been using so clean over 8 years. I have chronic sinus and respiratory issues I now fear just got worse over time by using this machine all this time. What to do now??

  35. Maureen

    I paid 300 dollars for this machine and was told that if I use it, my warranty would be voided for my Bipap machine. I want my money back.

  36. Patricia

    Bought SoClean because med supplier recommended and sold unit. Headaches, sore throat, thick mucus, runny nose, coughing, dry throat. Did not know anything about recall until today. Have COPD and continue to have breathing peoblems even on meds. Disabled, on Social Security and medicare. Need help please.

  37. Pam

    My husband and I both wear Cpap’s and have a SoClean machine as well. I was just looking into purchasing another SoClean machine to make it easier to clean our cushions, hoses ect at the same time and came across this lawsuit. WoW!! Very sad that a company would produce a product that would cause ill effects on the consumer. What is this world coming to!! Would definitely like a refund at the very least.

  38. Kenneth

    I have used a cpap for over ten years. I purchased the soclean machine in February 2019. Approximately 6 months after started experiencing sinus problems which have continually gotten worse. I have lost my since of smell completely, I have had sinus surgery, Taken every kind of medication and still wake up every morning miserable with sinus problems. Now i am finding out that the Soclean machine is the cause of everything.

  39. Joan

    I also have the so clean machine and also have health problems since using this machine runny nose, head aches, coughing, dry throat, dry nasal. I paid 300.00 for my machine and would like my money back.

  40. Terra

    So I bought the soclean for my husband to help keep his machine clean, he has had a lot of sinus infection and head colds in the past which I figured were allergies. But after he stopped using it he hasn’t been sick at all! I would like my 300.00 back!

  41. Phil

    I have developed lung issues in the last couple of years, I don’t know if they are related to the use of the So-CleanI. I would like to join the recall or at least get a refund since I no longer use it. Where do I sign-up?

  42. Dennis

    I used the SoClean 2 for years to “clean” my CPAP gear. Now i’m paying for it with being diagnosed with Hypoxic Respiratory failure

  43. Janice

    May we join the class action lawsuit? My husband and I both used SoClean until we heard about the issues they cause.

  44. Roland

    Am suffering from lung disease …. Thanks for the information will report back if I am terminal ……

  45. Lynn

    I bought a SoClean machine within the last 2 years. My husband has been sick with a stuffy nose and trouble breathing and has been taking allergy medicine and antibiotics for months with no improvement. The machine cost approximately $300.00. Can we get our money back?

  46. Juanita

    I bought the SoClean machine about 2019 because of easier sanitation of my cpap machine an had lung cancer in 2021 had stopped using my SoClean an cpap machine for long time, just started using again. Just found these comments and now I am wondering if its safe to use the SoClean with my cpap. My 3mo check up was good I go for my 6mo check up in December. I pray I am still good

  47. Tannette

    I have been using the soclean machine since 2016 and purchased the soclean 3 about a year ago. Since using the machine I have been experiencing extreme laryngitis, headaches and sore throat issues. Have gone to Dr and was given no explanation for the laryngitis. Realized that this is due to the use of the machine after reading the comments of others. How can I join the lawsuit? Can I at least get a refund for the two machines I’ve purchased?

  48. Lorelei

    Lots of throat mucus, unending, feel at times I can choke. Should have been warned. Had used for years! NO MORE!

  49. Scott

    I used the Phillips Respironics Dreamstation and the SoClean from September, 2020 until the Dreamstation died with a service error in June 2021. My provider took it back quickly without asking questions and sent me home with a ResMed machine. On my way out I noticed they sold the SoClean on display and I said I needed the adapter to work with my ResMed. He said stop using the SoClean and ushered me out the door. It was very odd indeed but now I know why.

    I’m not happy. I am not sure if this has damaged me but I now have a pacemaker and other medical issues.

  50. Arthur

    Because of the issue raised by Philips, I disposed of two SoClean units and spare filters. Is it possible to recover the costs or obtain replacement SoClean units from Philips?

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