KL Owen Custom Orthodontic Solution recall (Klowen Braces)
Medical deviceClass IIOngoing
Summary: Klowen Braces is recalling KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,. Reason: A product error defect may cause incorrect bracket placement.
What is being recalled
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Why
A product error defect may cause incorrect bracket placement.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of OH, TX, SC VA. (states named: Ohio, South Carolina, Texas, Virginia)
How to tell if yours is affected
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2699-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 8, 2026 |
| Reported | July 15, 2026 |
| Company | Klowen Braces |
| Company location | Richardson, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 units |
More recalls from Klowen Braces · all medical device recalls · recalls from June 2026