SoClean 2 & 3 Voluntary Recall
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- Опубликовано: 28 янв 2025
- Link to the recall page - cpap.review/so...
Medwatch Reporting Form - cpap.review/me...
SoClean has voluntarily recalled its SoClean2 and SoClean3 devices, used for cleaning CPAP machines, following approximately 7,417 complaints (0.33% of units sold). These complaints often involved difficulty in setting up or turning on the device, unpleasant odors, cough, and worsening of preexisting conditions. The recall does not necessitate users to cease use or return their units.
SoClean is updating its labels to include additional warnings, contraindications, and clear set-up instructions, specifically emphasizing the use of the provided hose and mask adapter. This move aims to address risks associated with the previous device design and labeling.
The FDA has issued safety communications advising users not to use SoClean2 or SoClean3 without the provided adapter, to disconnect the equipment from CPAP devices during use, and to follow CPAP manufacturers' cleaning instructions. The SoClean manual and the new adapter are designed to reduce ozone exposure risks. The FDA continues to work with SoClean for compliance and reminds that no ozone gas or UV light-based cleaning devices for CPAP machines have been authorized for market. Problems with SoClean devices can be reported through the MedWatch voluntary reporting form.
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Thanks for the support
Cheers
Nicko
I've been on CPAP therapy for 8 years now and I've never used one of these cleaning machines. I typically clean my tubing every couple of weeks with some warm water and a little Dawn. Haven't had any problems the entire time owning my machine. Cheers, Uncle Nico.
Cheers bro, i think that says it all
Pretty much all doctors say tubing should be cleaned at least once a week.
I love you work very clear explanation. Very professional. We learn a lot from you . Thank you . Sam
I appreciate that!
I have some auto immune disorders and take medication that weakens my immune system. So I get sick very fast.
What’s the absolute best way to clean cpap? I tried cleaning once a week where i dump everything in a tub with warm water and dish soap and lightly dunk and rinse it in the tub then leave it soaking in there for like an hour and then air dry for the rest of the day. I still got sick unfortunately
I've always thought these were a bad idea. I use an ozone cleaner that you put in a bag with the hose and mask. I also blow air through the tubing and mask before using.
I blew a wad of cash on one of those SoClean machines, but what I don't understand is how would using a SoClean machine allow for ozone gas to travel through the machine itself? The fitting w/ hose snaps onto the neck of the humidifier & I can understand how the humidifier chamber would get ozone gas introduced into it (by means of the small 1/4" hose that goes down & into the clear plastic water reservoir), but the ozone gas goes back up & through the cpap hose & into the mask that is placed in the SoClean machine. To me it would seem that the ozone gas doesn't even pass through the through the cpap machine at all, with the exception being that the ozone gas does go into the water chamber.
Am I missing something here? Thanks for your help.
Thanks again for looking out for this community. You do your research! 👍
I feel like a 0.33% product defect on the old Phillips CPAP was within limits of a normal manufacturing defect rate, or customer sensitivity. It's a real shame that the manufacturers dump the blame on so clean. I used the normal setup on so clean with the Philips and have continued to use it the same way with ResMed for 7 years now with zero problems. I clean all of the parts out with soap and water every 2 weeks but I use the ozone cleaner CPAP every night. I've had no mold I'm had no issues with bacteria.
I use one for my hose and mask. Disconnect from cpap and use adapter from hardware store (sprinkler adapter) that matches mask hose and small black tube size.
If it stops ozone from getting in the cpap, how will ozone clean the machine
It won't, they don't want it getting into the machine because it's very clear it causes big problems. Cheers
Aren't ozone generator cpap cleaning devices one of the causes of cpap foam disintegration?
How’s the best way to kill mold out of the cpap units if the machine was exposed to mold ?
It would suck if mold is in the cpap unit and ozone is the best way to neutralize it
Is there a better cpap cleaning device to out even mold?
Does this recall include the damage to the foam sound dampening ring iniside the ResMmed AirSense 10?
it will damage that disc over time!
NO!
It is only a replacement hose connector and a new End User booklet.
SoClean does not care about your Cpap machine.
I think this new connector removes the special tank for the AirSense10 and connects just to the hose, removing the machine from the Ozone.
Been using the SoClean 2 for some years now. I had a philips travel machine which got recalled. I have since moved onto a ResMed travel unit. I have noticed a worsening cough. I use the SoClean everyday to clean my mask and hose that is attached to my machine via the adapter. My concern is I've been using it so long how do I know for sure it has not done more damage already?
I use the adapter piece furnished from SoCleans. It prevents ozone from going into the machine.Cleans the hose and mask only. The voluntary recall is actually the adapter free from SoCleans.
where to get the adapter?
I bought one years ago from a FSA website, but ended up barely using it because of the smell and my general distrust of it. 😂🎉
Me too. $280 down the drain. Used it 4 times but the stink was too bad. AirSense10 with the special water tank.
Same here but I wasted time & $$ on doctors visits sleep studies only to end up worse off than when I didn’t use the machine at all.
The latest filter kit I bought came with the new adapter and a sticker to put on the lid…
Does anyone use any other type of cleaning device such as a UV light one?
My son sent me the updated adaptor. I really don't understand it. Why they didn't include a repair part for the SoClean lid catch. The lid catch breaks on all SoClean machines. I have to put a heavy Stuffed animal character on top of the SoClean lid while using the machine in the morning. My routine: Put my mask in the machine and the small hose adaptor to the other end of the hose and run the machine. Take my shower and go now stairs for about an hour and have my coffee. Then when I go upstairs to change to my work uniform. I pull the hose out and let it air out. I don't understand the issue. At night I fill the reservoir & use my Cap.
100% do not use Ozone cleaning machines. Not only can it be dangerous to your health, but it can void warranties for CPAP machines.
I use it, no problems. Even CPAP retailers sell it. If it was such a big issue they would of stopped selling them along time ago.
I AGREE COMPLETELY. BUILD BETTER CPCAP MACHINES
I never bought one due to the extreme cost! I bought a cheaper cleaner and just my tube and headset in the bag and leave them out to air out. I manually wash my nasal pillow and occasionally wash out my hoses.
William Shatner was doing lots of commercials for this machine I think..haven’t seen them in a while now…
Yea, he sure was. Where is he now? Scotty must have beamed him up?
I have an ozone machine (Sleep 8) but it's the one that's only for the mask and hose and does not connect to the machine at all and I only use it once a week to sanitize in addition to the normal soap/water cleaning.
Get rid of it! None of this stuff is safe to even use in your home. Even worse to use on medical components you breathe through! Ozone is unstable and will turn into formaldehyde and other toxic chemicals. UV lights also create ozone.
Igualmente yo
Occasional use of a soclean isn't going to cause problems. Using it every single day will definitely break down foam, rubber and plastic though. Some people are forced to buy used cpap machines. Disinfecting a used machine is where the soclean really shines.
I use mine every day. I have done this for years. I have not had any issues. Ozone can be safe and effective when used properly. I worked in the food industry and ozone is used as a sanitizer in many food plants.. It is also used to sanitize wine barrels.
.If you have a SoClean and are still paranoid about ozone in your CPAP watch this . ruclips.net/video/Y1RDJ9iOSlk/видео.html
Yup ozone will form incredibly nasty compounds with most plastic materials, and can disolve into most plastics as well. As for the headgear mask and tube, just wash with mild dish soap and warm water. Rinse and dry. ❤
Cheers Chris
You're fundamentally wrong. I think you're confusing rubber with plastics. Plastics hold up to ozone quite well. www.nrc.gov/docs/ML1820/ML18207A768.pdf
Show us the new ADAPTOR, and it's new use.
Meh, there are millions out there and a tiny number of complaints. And a recall with new labels and instructions is weak tea at best. They are safe and effective when used properly. If they weren't there'd be a real recall or lawsuit. But, thanks for the video.
Maybe safe definitely not effective. I have wasted tons of time and $$ on doctors visits, sleep studies, having my settings checked and rechecked only to find that I sleep the same with or without the machine. I continue to wake up at night gasping for air. If I have the same sleep results with or without the machine I prefer to sleep without a piece of rubber strapped to my face. Well it did change one thing. I now wake up with excruciating headaches after I use it.
This video is not about the cpap machine. It's about the cleaning units and whether they are safe or not.
Its funny, i just used it for the first time last night. I took one wiff and i started coughing something wicked. I let the cpap run for 10 mins. No smell anymore
Just saw a review about SoClean 3 and wondered what the heck this device does. Does it replace cleaning? Enhance cleaning? Maybe it is a money grab?
Yup, a money grab. A company trying to give the impression a product does something worth while when in fact it just empties your pockets.
Shortly after starting using my SoClean 2 machine, I was diagnosed with Pulmonary Fibrosis 6 year’s ago. I stopped using the So Clean 2 machine once the problems developed with the Phillips machines. At the time I was using a ResMed 10 device. Any one else been diagnosed with any lung disease?
So…I’m wondering now, are all these machines and apparatuses meant to help us or kill us? 😂
i sometimes wonder the same thing!
Uncle Nico my tin foil hat says so clean is in bed with phillips if they had access to users data they could exclude all those folks from further litigation
Hey mate, nah, SoClean have a lawsuit out on Philips. Cheers
luv u uncle nico cheers@@CPAPReviews 😉
Hey Nick, The question is, "What can we do with those So Clean Machines now that we all purchased? $$ Are we simply stuck with them? Or is there any chance there will be any retribution about them?@@CPAPReviews
Thanks.................... That's all I need to know. Frankly, I'm always skeptical of everything anymore. Seems like there is a plethora of things out there that are designed to benefit you that only help end your life, like Boeing aircraft.
Ya' know, if folks would stop being lazy and just simply take a few minutes----yes, just a few minutes from start to finish---to clean their CPAP gear in warm soapy water (or warm water with a bit of vinegar) these silly recalls wouldn't be needed because nobody would be using this Snake oil BS.
Not so much 'snake oil' as unnecessary sanitising. Overkill sanitisation. Plus it will damage the machine internally due to the way ozone and UV work.
these ozone cleaners are bunk; a waste of money. warm, soapy water and some rubbing alcohol is all you need.
What do you use rubbing alcohol on?
Laundry soap and warm water. Rinse with warm water. Dry everything out etc.
The machine itself you don't need to clean.
I use p2 face mask material and cut out intake filter sized pieces, sit it behind the original intake filter, then add another .5 cm of air pressure to the bottom and top pressure. Done.
I use 91% rubbing alcohol and fill the tube about 1/3-1/4 of the way and then add warm-to-hot water until the tube is completely filled. I then put one end into the other and slosh it around a bit before leaving it in the sink for about 10-15 minutes. Afterwards, I completely rinse with warm water and I let it hang dry for the rest of the day.
For the mask, I use a bottle brush (that is used only for this), with some dish soap, and again, thoroughly rinse. with warm water. I tend to use non-scented or lightly scented soaps because that smell can really stick around.
The machine itself just needs a clean, soft towel to wipe off any dust.@@areowl8194
They are worse than bunk, they can be extremely harmful. Ozone will both degrade and absorb into plastics. Breathing ozonides, organic peroxide, aldehydes and acryl chlorides every night will definitely do worse to your lungs than even smoking a couple packs of 🚬 a day 💀
Soak all parts in either warm soapy water or warm water and vinigar nothing els machine itself never needs to be touched cleaned or even wiped just soak the parts rinse and set dry that's all
I never understood these cleaning devices. On top of ozone being unhealthy, but ozone also damages plastics, so it reduces the life of your equipment. Ditto for ultraviolet light!
Please feel free to cite your research that ozone damages plastics (as opposed to rubber).