SoClean 2 recall
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Why was SoClean 2 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPC: 187293000860
- Product
- SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
- Recalling firm
- SoClean, Inc
- Quantity
- 2,339,352
- Distribution
- 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.
- Recall date
- January 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)