FDA Medical devices recall ·
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033 recall
- Recall number
- Z-2699-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- Klowen Braces
1900 Firman Dr Ste 800, Richardson, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Why was it recalled?
A product error defect may cause incorrect bracket placement.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Distribution
US Nationwide distribution in the states of OH, TX, SC VA.
States: Ohio South Carolina Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2699-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.