Reported Jul 15, 2026 · Ongoing

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
    • 1779407586392-0
    • 1779138889952-0
    • 1778173992342-0
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.