Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0695-2024 — SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.

U.S. FDA — Device Enforcement · United States · 2023-11-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0695-2024
Date of alert
2023-11-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SoClean, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
187293000860
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.