Reported Jul 15, 2026 · Ongoing · Updated Sep 16, 2026
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Klowen Braces
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Klowen Braces · 1900 Firman Dr Ste 800 · Richardson, TX · 75081-6769
Is this the product you have?
- KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
- Lot codes and dates
- UDI/DI 10850061082029
- Lot Numbers
1779407586392-01779138889952-01778173992342-0
- Amount recalled
- 3 units
Where it was sold
Why it was recalled
A product error defect may cause incorrect bracket placement.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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