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FDAFDA · Food and drugs·Recall number Z-2699-2026

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Published July 15, 2026 · Recall initiated: June 8, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

A product error defect may cause incorrect bracket placement.

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Klowen Braces
Distributor
US Nationwide distribution in the states of OH, TX, SC VA.
Lot
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Risk classification
Class II
Area (FDA)
device
Country
United States

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