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SoClean, Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.Class IINov 15, 2023New User Manual with additional instructions for use and a h
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance SystemClass IINov 15, 2023New User Manual with additional instructions for use and a h

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