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

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.

SOCLEAN LAWSUIT:

Did you experience health problems after using SoClean to sanitize your CPAP machine?

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.


266 Comments


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.

Mark
Put me on the list, big expensive paper weight.

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.

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.

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.

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!

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?

Richard
Statement below, not going to repeat.

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.

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?

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?

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.

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.

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

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.

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.

Michael
I have been using So Clean to sanitize my Res-Med Cpap for about 1.5 years. I only use it 3 or 4 X/week. I’ve woken every morning for the last plus year with extreme nausea and congestion and cannot figure out what it is. My doctor lowered my Trulicity dose but the nausea persisted so have stopped all together. Now I read all this stuff about the So Clean and I wonder if its the So Clean.

David
I live in Nova Scotia, is there any recourse in this province to get a refund

SANDY
Why has the Federal Government allowed SoClean to continue to sell this product knowing that it is not FDA approved and putting millions of lives at risk. Every Attorney General in every state needs to be pursuing this matter with vigor in order to protect the citizens of this country. This company needs to be shut down and all the money of those who have purchased one of their machines should be returned to them. This is fraud in it’s purest form. I remember asking the representative from this company if this machine was FDA approved and she told me yes it was. This is an outrage and should be federally investigated by the Justice Department.

Marc
. I have since stopped my SoClean using it. The reason is I noticed black dots of stuff in my water chamber. Didn’t think much of it for awhile. But it continued and started getting worse. . I woke up congested almost every day. I beleive the congestion is caused by what ever is deteriorating within my machine. I get a warning every day that my machine has outlived its life expectancy. I’m quite sure this is caused by the So Clean so I am in the process of getting a new machine. I will not use the Soclean again and would like to be refunded the cost of the machine. And possibly more for possible health issues down the road. This is very concerning to me. What have I been breathing in?

Dominic
I would like my money back as well. I stop using the So Clean machine because my friends doctor told him to stop using it. I had a dry cough for a long time but its need a bit better since I stopped using it.

Melva
I used the so clean machine to sanitizer my cpap and I woke up every morning with a headache and stuffy head throat was dry and sore. I want to be compensated for the damage it has caused and loss of time from not being able to have a cpap.

Kevin
So Clean owner with recalled Philips DreamStation. Wheezing, dry cough. asthma like symptoms.

Arnold
I want my money back!

David
I cannot believe that the FDA allowed So Clean to advertise and sell a product that could be hazardous to the health of the user. The FDA seems to be very vigilant about approving drugs without extensive trials. And yet they allow a product that could lead to injury or death to be sold and don’t lift a finger. I have a $300 machine that I haven’t used in almost 2 years sitting on my nightstand. It isn’t even heavy enough to be a boat anchor!! What a lousy deal!!

Sharon & John
We bought two machines and my doctor told us to quit using them immediately. Is it possible to get a refund?

Lisa
I bought a so clean in 2018. I have since stopped using it because I have a cpap that has been recalled. I woke up congested and with headaches almost every day. I had a sore throat and my mouth and nose were very dry. I will not use the so clean again and would like to be refunded the cost of the machine.

Thomas
I don’t think I have any problems caused by the SoClean but I could smell the ozone from the machine. My wife said it was bothering her so I quit using it. I would like to get a refund for the cost of the machine.

Thomas
I don’t think I have any problems caused by the SoClean but I could smell the ozone from the machine. My wife said it was bothering her so I quit using it. I would like to get a refund for the cost of the machine.

Linda
My husband had many issues during his So Clean uses to the point that he passed away on March 3, 2022 he simply could not breathe!!!!! In the last months, no one could explain why this sudden severe problem! ( including all his physicians ) He wound up with severe lung issues such as pseudomonas which he has had in the past during so clean uses and therefore truly didn’t want to use it again, however, believed it to be much better and efficient. I am truly in disbelief as I read these stories GOOD GOD is this why?

Donna
I have been using the So Clean machine for approximately 3 years. I never understood why I would wake up so congested, with sore and scratchy throat, brain fog, hoarse voice, headaches., coughing, etc. I didn’t understand because the doctor had told me that the cpap would make me feel more rested but I was more tired than when I wasn’t on cpap! However, I was using the So Clean machine along with the cpap machine and I never made the connection that it could be causing the problems. I thought I was doing the right thing by cleaning with the So Clean. I have been off of the So Clean now for 3 weeks since my sleep doctor and technician told me to stop right away. Don’t know why no one told me before this time. Since stopping the So Clean, my voice is finally becoming less scratchy/hoarse. The congestion, headaches, and other symptoms are subsiding so I tend to think that was causing the problems. I have no idea if there was any permanent damage done or if it is just the temporary symptoms I experienced. It is scary to think permanent damage could have possible been done….especially when you are trying to take care of yourself and do the right thing.

Soozi
I used my so clean and began noticing black specs when I washed the tray. I realize now that I had started having sinus issues , sore throats and extreme sensitivity to new medications after I purchased and relied on SoClean to sanitize my equipment.. I don’t know what other health issues this machine will cause me in the future.. it’s very frightening to think of what could happen to me because I trusted the commercials and this company..

Jack
In 2018, we purchased a So Clean CPAP cleaner, within 2 months I had to have a pacemaker placed. Since starting to use So Clean, I am always dizzy, have very severe headaches, brain fog/memory problems, severe fatigue, coughing, burning eyes, shortness of breath and constant itching. These symptoms are ongoing. I’ve also had a lung bleed in both lungs leaving me on oxygen 24/7 and damage in my lungs. I had to stop working due to the constant illness. There are more difficulties. I only found out about this issue with So Clean a couple of days ago, I wish I had know before there was permanent damage.

Dollie
A few days ago, I started noticing Black and green stuff floating in the water chamber. I cleaned the chamber often. When I saw that stuff in the water chamber two days ago, I stopped using the SoClean machine. I have been using this machine for years!!! Why wasn’t I notified that this machine is a big LIE ? This is CRAZY!!! The machines aren’t cheap. Now I have to worry about how it has affected my health. I only noticed the complaints when I was looking for the SoClean customer service to complain about the stuff floating in the water chamber . These companies just don’t care. It’s all about the dollar. I definitely want my money back and want to be part of the class action .

Pamela
I didn’t know about this! I noticed the water tank getting brown but thought it was from dust accumulating because I live in an agricultural area. I too have been getting sore throats, headaches & sinus problems but I also suffer from allergies. I’m exhausted all the time too! Dictionary have had me go through all kinds of testing but have no explanation for my issues. They tell me to get more sleep, drink more fluids, take allergy pills, etc… I’m going to stop using my so clean tonight & see if some of my symptoms subside. I’m glad I ran across this article!

Kristen
I just want my money back on the SoClean…

larry
I used so clean for about14 months. I developed ILD and kept getting sicker. eventually I had to have a double lung transplant, kidney disease and other ailments. Be fore being told by the doctor to use a cpap I was very healthy. Within 5 months I could no longer work. I was on an oxygen tank 24/7. I used the Resmed cpap which worked well for me untill I added the soclean.

Sandy
Why was I just told not to use my SO CLEAN now when the Recall was over a year ago. Who dropped the ball on this one? I

Ruth
I have been using so clean for the past 2 years. I often experience a sore throat

Larry
Have developed sinus problems, extreme sneezing, and headaches after using my soclean. Also turns my mask a weird brown shade. Called them and they told me this was normal. I will quit using this Chinese made piece of junk.

Marlene
I have been using the machine for years. No I have been diagnosed with severe allergies and asthma. How do I get a refund

Sharon
I bought a so clean, advised not to use it. Got a new replacement as far as CPAP goes. I want a refund for my so clean. I still have it but how do I get a refund?

Darrell
I have been using a so clean to clean my res=med c-pap for years and now I have skin cancer, lung problems and bad headaches. I would like to know if I can have something done about it.

Harry
I have the so clean 2 and I discontinued use after noticing the equipment was turning brown, at the time I never really paid too much attention to me coughing after putting the machine to use at night. I do have a persistent cough after discontinuing use of the cleaning machine. I truly believe after I see how this cleaning process turns material brown, and the persistent coughing this device is causing equipment and health damage. I would like to join with others in these actions against the soclean product thats causing equipment failure and health issues.

Valerie
Been trying to get my money back for Four so clean machine That I bought for my children but as I did the research they found out that so cleaning is being sued for the ozone gas and then they talked it over with there doctors and the doctor told them not to use the machine I’ve talked to so clean and text them several occasions and they refuse to give me a refund so I have four unused so clean machine gathering dust So my question to you can you help me get my money back!!!!

Kathryn
I too have the sinus and headache and I was going to talk to my doctor. Headaches last several days.

James
I have been using a so clean for approximately 3 years. Since then, thought I was developing allergies and never thought about this being caused by a machine I was supposed to be helping me clean my vpap machine. Started with stuffy nose and headaches a year ago. Progressively got worse started sneezing a lot and then sinus drainage out of control. As time went on symptoms have worsened, Shortness of breath, dizzy, exhausted. Talk to Dr they figure allergies and prescribed meds. Did not get better. Thank goodness time came for new cpap machine ordered and was told not to use so clean with new machine. Looked into reasons and found this article. Sad to see everybody from so clean, cpap suppliers and FDA have not published more notice on this. Week ago, STOPPED using so clean things getting a little better but still have some symptoms wonder how many symptoms I will have permanent.

LINDA
I have not been notified from SoClean2. Used it 2 years. Smelled chlorine smell but thought it was after odor of a 99.99% cleaning cycle. Had headaches, inhaling breathing odd feelings. Concerned for future time bomb. I never smoked, ever.

Ruben
I have developed a persistent cough for weeks, didn’t know what was causing it till I realized that my cough got much worst at bedtime after putting on my cpap gear after removing it from the soclean machine, I need to know if there’s an existing class action suit against the makers of this soclean machines or what to do. I hope it has not caused long lasting breathing problems for me, please, if there’s a class action suit some please let me know. Ruben

Loretta
I have used the so clean 2 for several years and when my machine was recalled I called so clean and they told me nothing was wrong with it and I want to know why I never received anything about the class action lawsuit I still have it and it was registered with soclean

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