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very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
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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
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 23, 2026 at 11:04 PM UTC.
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