CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report

SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment recalled

SoClean is recalling SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment, distributed nationwide in the US. The recall was initiated on 15 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)00858242007147

Quantity recalled40,075

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0694-2024
FDA event ID: 93570
Recalling firm: SoClean, Peterborough, NH
Classification: Class II
Status: Ongoing
Recall initiated: 15 Nov 2023
FDA classified: 10 Jan 2024
Reported: 17 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Nov 2023	Recall initiated by company
10 Jan 2024	Classified by FDA	+56 days
17 Jan 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.

Product as listed by the FDA

SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

Where it was distributed

Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, New Zealand, Portugal, Russia, Saudi Arabia, Seoul, Singapore, Spain, Sri Lanka, Switzerland, Thailand, Netherlands, Turkey, United Arab Emirates, and United Kingdom.

Nationwide

Questions about this recall

Is SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment recalled?

Yes. SoClean recalled SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment on 15 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0694-2024.

Why was it recalled?

Which lots are affected?

UDI: (01)00858242007147

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from SoClean

All 2

Reported	Class	Recall	Company	Reason	Where
17 Jan 2024Device	CLASS II	SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System recalled	SoClean	Other	Nationwide

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