FDAClass II · Medical device · Recalled July 15, 2026

KL Owen Custom Orthodontic Solution recall — Klowen Braces

Hazard: A product error defect may cause incorrect bracket placement.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2699-2026
Brand: Klowen Braces
Classification: Class II
Units affected: 3 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

KL Owen Custom Orthodontic Solution

Companies & origin

Recalling firm location: Richardson, TX, United States
Firm address: 1900 Firman Dr Ste 800, N/A, 75081-6769

Identifying details (verbatim from the notice)

Product codes / lots: UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Distribution: US Nationwide distribution in the states of OH, TX, SC VA.
Firm notified the public via: Telephone
FDA event ID: 99277
Recall initiated: June 8, 2026
FDA classified: July 8, 2026
FDA report date: July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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