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. Del

    I’ve been using the so-clean for a couple years now and I have a cough that I can’t get rid of. Please keep us all posted on what we should be doing. I’m for sure not using my so-clean.

  2. Diana

    Like to be part of class action lawsuit

  3. Charlene

    I’ve also used SoClean for 4 years and have developed an unexplained cough. Please include me in this lawsuit.

  4. David

    I have been using the soclean 2 for about 3years. On my brithday in 2019 I was diagnosed with Amyloid Osis that is destroying my liver, kidneys and heart. I’m just now reading the reports of the dangers of ozone emitting devices like this. I have always wondered about the smell, but trusted the machine that I thought was FDA approved. I will never use this machine again, and would like to be include in any and all law suits against soclean and Philips.

  5. Stan

    Been using SoClean for a few years constantly and have headaches and coughing. How do it get included in lawsuit?

  6. Tammy

    My husband and I both use the so clean machine I have been using it for 4 years now and he has been for almost a year.I wake up with headaches bad in the morning. I have asthma and it has gotten worse I would like to get in on the law suit

  7. Darrin

    Have been using SoClean and have developed sinus and cough issues. I believe I will stop using the device and go back to hand cleaning and see what happens.

  8. Michael

    I purchased my SoClean 2.5 years ago. I used it daily. It always had a strong ozone smell from residual gas trapped in the mask and hose. About 8 months ago I was looking at prelims for knee surgery. I mentioned I was having some slight chest and jaw pain. My doctor ordered EKG’s, sonograms, and lower, heart and carotid flow sans and an upper MRI. I have been scheduled to see a cardiologist in January. After reading several articles , I believe the excessive ozone may have contributed. I have ceased all use and will not use or recommend this product. I use a ResMed CPAP, and have for over 20 years without issue If it helps I will participate.

  9. PATRICIA

    Been using a so clean for about 1 and 1/2 years
    I have noticed the smell and have increasing headaches as time goes by. Would like to get involved with the law suot.

  10. Tim

    I have been using a So Clean for several years how can I participate in the class action lawsuit?

  11. angela

    I have been using So Clean for 3 years. I am having such eye problems, dry eye, fungus and am on eye drops. Totally changes the quality of life when you are so focused on your eyes…Have been to the eye doctors several times…I would like to be included in the lawsuit if I can.

  12. Amy

    I am just falling on this page as I was searching on how to clean the soclean. I wake up in the middle of the night and mornings with a very runny nose and eyes. I guess I will clean my cpap machine really good and not use the soclean going forward especially after reading these other comments.

  13. Donald

    I purchased a SoClean2 in 2018 and have since been bothered with runny nose, chronic headaches, and dry eye. The VA recently warned me that this could be caused by the Ozone created by cartridge filter. The VA actually does not recommend using the SoClean2 or any product that creates Ozone.
    I would like to join the class action suit that is currently active.

  14. John

    I have been using the SoClean since about 2013 or 2014! That can likely be confirmed with the serial # on my machine. I got it soon after thry came out because it was sibeasy to use. I have developed a persistsnt productive cough, sometimes irritated nose as well. I have many photos of the crap I’ve been coughing up! I just found out about the issues with SoClean. They never contacted me or gave any warning of the potential health issues. And also found that mt CPAP machine ResMed does not cover damages caused by the SoClean machine. Now I am very worried about health effects & potential cancer. I if course have stopped using the SoClean machine 2 weeks ago.

  15. Ann

    Since using this machine my headaches an coughing has increased

  16. Daniel

    I’d like to be part of the lawsuit. I had headaches and dry nose and my masks turn yellow I stopped using it. Felt fine

  17. Sara

    Just found out about SoClean. I have been waking up with headaches and my nose is always runny. I called the company and was told their machines are perfectly safe and there is nothing they can do to reimburse me. I would like to be a part of the lawsuit and would like to get the word out there to others that are not aware like I was until I saw my doctor.

  18. Abbie

    I bought SoClean last January and just learned of this. I immediately stopped using and called the company to ask for a refund. I was denied and refund, and the man I spoke with was very rude. It was very expensive and now I can’t use it. I get sinus pressure, headaches and other respiratory symptoms. Please include me in the lawsuit.

  19. Marcia

    I just found out that the Soclean is giving troubles as well as the Dreamstation Bipap (I started with a cpap and got worse so I was changed to Bipap). I am so use to the bipap I cant sleep because I stop breathing so many times a minute. I am annoyed that I am trapped into using it and it is taking so long to replace. My health detoriates and I find that what I trusted to help me is not good for me?

  20. Larry

    I purchased a SoClean model SC1200 in May 2019. I now suffer from extreme dry eyes, constant mild headaches and runny nose. I would like to join in the class action suit.

  21. Vince

    I have been using my soclean for about 4 years and am getting the same symtoms as other users. Headaches and cough and dry eyes. I thought it was allergies. I believed my Soclean machine was supposed to prevent any air borne problems in my hoses and c-pap machine! I would like to be included in this law suit as well. Very disturbed over this!

  22. Albert

    I have been using my SoClean CPAP cleaner for over three years now and wondered why I was coming down with more respiratory problems than normal. I chalked it up to allergies.
    I have a Philips Dream Station

  23. Frank

    Purchased this product 2-3 yrs ago, love it, does exactly what it claims to do. ABSOLUTELY no side effects, you can always get lawyers to file civil suits any day of the week. It’s all about the money and it’s done everyday…

  24. David

    I got my so clean machine because I was having health issues be careful CPAP is dangerous though I always keep mine very clean i took the machine apart and found the blower motor was full of mold

  25. Jack Ruiter

    Got in 2017 really liked it. Just found out today when I tried to order a new filter kit the therapy shop no longer sells them told me to stop using immediately.i was diagnosed with off in 2020 down to 35 percent lungs . don’t know what caused it but this could be the cause.

  26. Juanita

    I really have all symptoms discussed and they have gotten worse . Want to be included in this law suit. Please tell me what I need to do. My pulmonary doctor told me to stop using the so clean machine.

  27. Sherry

    Per all this information concerning the SoClean Machine and CPAP Machine, when the SoClean came out I purchased it which was I think in 2016 and I have been on CPAP for sleep Apenea with Hypersomia since 2000. Certainly I thought my headaches, sinus problems, dry eyes, extremely runny nose (which also gets very dry and bloody) and just altogether not feeling well is allergies and sinus infections. So if at all possible I to would like to be included in the lawsuit. Thank you
    Sherry

  28. William

    I was just told by my sleep therapy nurse the soclean would degrade my CPAP how can I sign up for the law suit

  29. William

    I have a So Clean and have problems also. Can I join lawsuit
    Thanks
    Bill

  30. Sherry

    I have used the soclean for years to sanitize my ResMed Air Sense 10. I have a constant rash/blister/severe itch where my mask touches my face. I thought I was having a reaction to the silicone on the mask. I saw 4 dermatologist and they were no help. I was told I just have sensitive skin. No I’m wondering if the ozone is remaining on the mask and giving me chemical burns. I can not sleep without a CPAP. I will stop breathing. I’m not overweight and I live a healthy lifestyle. I have had breathing problems sense birth. My lungs collapsed as a baby.
    I have also had massive drainage in my sinus and chronic sinus infections. Dr says it’s allergies…. Help…. I want to be included in your lawsuit.

  31. Jacqueline

    My husband and I have been using a soclean machine for several years now. We have both experienced headaches, runny nose, sore throat, and the smell was almost unbearable. Also my husband has had bladder cancer. Please add us to the lawsuit as we feel we have been mislead. And have had problems because of it.

  32. Vance

    Have used my SoClean for about one year. I have a constant runney nose, with blood when I sneaz . I do not know if this is a result of my SoClean, but it sure seems possible, reading other comments. Why did the FDA stop the makers of SoClean with using ozone was used for cleaning. I am 77 years old and may be dead before this case is settled, but I hope it stops So Clean from selling DEATH.

  33. Rick

    My wife has been using the SoClean for approximately 2 yrs. For the past year, she has been experiencing blisters/soreness around her nose. Lately, she has developed allergy like symptoms for days following use of the SoClean.
    Is this lawsuit pertain to Canadian consumers as well?

  34. Gary

    I have been using a now recalled BIPAP machine since 2014. Shortly after my respiratory doctor set me up with it I purchased a Clean2 machine.
    I have been having recurring sinus infections and horrible tasting drainage from my sinuses for four years now.
    For the last year and a half I have been in the hospital for constant dizziness and migraine headaches that have continued to get worse with time.
    Two different health care systems with all of their tests and scans can’t find the cause of these debilitating symptoms.
    After waiting since June for a replacement or repair for my BIPAP machine, for no result. I disassembled my BIPAP machine to remove the suspect foam. What I discovered was, there was about ten percent of the original foam left. It was pieces about an eighth inch thick that was gooey and sticky throughout the air passages of the machine. I removed the foam and cleaned all parts of the machine. I have the foam that was removed from the machine.
    I blame the ozone producing Clean2 machine with daily use for this degradation of the foam in my machine and constant health issues.
    Please include me in your suit against this manufacturing company and partners.

  35. Robert

    Been using so clean for 2 years, have been developing a rash around nose & areas where mask touch my face. also my nose plugs up alot. maybe this could be the reason. been to dermatologist for the rash & they cannot determine the cause. I’ve been on CPAP for 20 + years and never a rash.

  36. James

    I have a ResMed 10 and have used a SoClean 2 for about 2 years. It has now deteriorated the foam. I have found foam in the water tank and the motor.

  37. MARK

    Please add me to the class action. I have continuing medical issues since I have been using it

  38. Vance

    I have used my SoClean for about one year. When I blow my nose, my tissue is often bloody. I often wonder, how can a company make a device that produces a dangerious gas (ozone). Sure, hospitals use ozone for cleaning, but in an empty room. I hope that a bloody nose is the only result of my use of my use of my So Clean machine. I have stopped the use of my SO CLEAN machine.

  39. R

    I purchased the SoClean approximately 2-3 yrs ago thinking that I was doing the right thing to keep my CPAP clean but after awhile my COPD was getting worse. I found myself very short of breath always sneezing very congested. Just recently I found out that there was a recall on the SoClean machine and I have stopped using it and I find that my breathing is not so labored and don’t have so much congestion and I am not sneezing. I want to be included in this law suit. Could you please provide information on how I can be included in this law suit?

  40. Anthony

    My so clean is 3 years old. The lid latch broke.Called So Clean and they said they do make a replacement lid part. But they give a discount price if it older than 2 years. The lid latch is so cheep Not well built machine for over $300.00. Don’t buy this product.

  41. Vicki

    Spent over $300 on machine I have been told is unsafe to use. I too have had issues with breaking out and breathing issues. At this point is it because of the So Clean machine or the Dream Station CPAP or both? I believe So Clean should refund if they are the problem. If the machine is not effective in cleaning as was sold to do then should be refunded.

  42. jeffrey

    i was advised by my sleep insomnia doctor to stop using my soclean machine for they are claiming its causing the plastic to become cancerous ive been using it for years in trusting the machine was safe now i hear this? very disappointed

  43. Milan

    was diagnosed with bladder cancer

  44. Clifford

    I have been on the Resmed AirCurve 10 for about seven years and have had the
    So Clean 2 for almost that long. Last year I began seeing rubbery particles in the
    water tank and when I took the Resmed apart, the foam disk inside was falling
    apart and severely deteriorated. I have stopped using the So Clean. Called my
    CPAP supplier and they tried to get a new foam disk from Resmed but they refused to supply it. They want the machine sent back to them but the CPAP
    supplier has no machines to give me a loaner due to COVID issues.I cannot go for weeks without the CPAP if it is sent back to Resmed for repair.
    Totally disgusted with Resmed and their policies.

  45. Bernard

    just been told so-clean sanitorizors are dangerous,i am concearned because i am showing some of the symptoms,rash around nose andplugged sinuses,wonder what i should do besides stop using it?

  46. David

    How do I know if I am eligible to join the lawsuit. Been using the SoClean for a few years. Thx

  47. Elbert

    After using, a lot of popping and bubbling sounds in my lungs as I breathe.

  48. John

    purchased soclean2 may 17 2021. went on line and registered the device same day with soclean. was told by my provider do not use any more approx 4 months ago. before using slept ok. now i have since started having more congestion, sinus burning sensations and cough A LOT MORE. I was not informed about this from SOCLEAN ABOUT THE PROBLEM!!!! THIS IS VERY MUCH WRONG ON THEIR PART!!!!!!! reguardless who is at falt SOCLEAN OR RESPIRONICS DREAMSTATION(PHILLIPS) THIS MUST BE FIXED!!!!!!!!! ANOTHER THING LOCATED IN OUR BEDROOM, MY WIFE HAS STARTED HAVING SOME RESPIRATORY ISSUES. WHAT TO DO WE ARE BOTH 71 YEARS OLD????????

  49. John

    I purchased my soclean2 couple years ago I would like included in on law suit

  50. Lori

    I would like to be contacted about the So Clean lawsuits. Both my dad and step-dad own units, and both experience issues as described in the literature I have read on this site and various others. My step-dad discontinued his usage after the chemical smell became so significant to his well-being. Respiratory infections have become far greater and occur more often since he was introduced to this system.

    My dad is currently in post surgery rehab recuperating from quadruple bypass. His machine was used until he suffered a heart attack in late December. His cpap has been recalled as well. My dad has suffered numerous ailments…all of which baffled his doctors, so many symptoms could not be alleviated/ eradicated. Constant sores and nasal drainage, extreme confusion…not dementia or alzheimers per neurologist. Suggested it may be covid fog, dizziness and headaches…he has never suffered from these, falls, lack of balance resulted in him walking like a toddler, anxiety, depression that wouldn’t respond to numerous meds, unexplained pain in limbs, and six blockages…3 Stent failures and 3 new ones almost entirely blocked. Cardiologist and primary all assured him his heart was in rhythm and everything was great! Yet, not so much. Honestly there is much more, but I will stop. Please contact me, and I can give the separate names or inform me of what we need to do. My mother has been in Respiratory care of home health and her company has been the supplier to both of my dads. To see all the issues surrounding the cpaps and this cleaner really angers me. Shame on you FDA…reminds me of the lax laws surrounding p.meds/ powerful companies as I saw unfold on the Hulu Docuseries DOPESICK. This really opened my eyes to the FDA and really how unprotected we citizens are when we put so much trust into our health system.

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