Reported Jan 17, 2024 · Ongoing

SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.

SoClean, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SoClean, Inc · 1 Vose Farm Rd · Peterborough, NH · 03458-2128

Is this the product you have?

  • SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Lot codes and dates
  • UPC187293000860
Amount recalled
2,339,352

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.