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CLASS II · ModerateFDA

Klowen Braces recalls KL Owen Custom Orthodontic Solution

📅 Jun 8, 2026 · 📍 Nationwide
Recalling company
Klowen Braces
Product
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Reason
A product error defect may cause incorrect bracket placement.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 8, 2026
Reported
Jul 15, 2026
Distribution
US Nationwide distribution in the states of OH, TX, SC VA.
Status
Ongoing
Quantity
3 units
Lot / codes
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Company location
Richardson, TX
Recall type
Voluntary: Firm initiated
Recall number
Z-2699-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2699-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.