FDAHealthJune 8, 2026
Klowen Braces — KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
⚠️ A product error defect may cause incorrect bracket placement.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 8, 2026
US Nationwide distribution in the states of OH, TX, SC VA.
What's affected?
- Product
- KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
- Brand
- Klowen Braces
- Lot code
- 1779407586392-0
Additional details
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3 units.
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