Exact FDA event identifier

Event 93570

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 15, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: SoClean, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

Z-0694-2024

Recall number: Z-0694-2024
Initiated: November 15, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SoClean, Inc
Quantity: 40,075

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI: (01)00858242007147

Distribution pattern

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.

device · product 2 of 2

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

Z-0695-2024

Recall number: Z-0695-2024
Initiated: November 15, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SoClean, Inc
Quantity: 2,339,352

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

UPC: 187293000860