⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-07-15

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Klowen Braces
Product
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Reason / hazard
A product error defect may cause incorrect bracket placement.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of OH, TX, SC VA.
Recall initiated
2026-06-08
Code info
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Product quantity
3 units
Voluntary mandated
Voluntary: Firm initiated
City
Richardson
State
TX
Country
United States
Event id
99277
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