RegWardenFDA facility compliance records
Company

SoClean, Inc.

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2023: 1 recalls20172018201920202021202212023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-11-15
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SoClean, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10039873-soclean-inc/

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