FDA recall, , Moderate risk
KL Owen Custom Orthodontic Solution
The orthodontic solution has a product error defect that may cause incorrect bracket placement.
Summary by Recall Canary from the FDA notice
What happened
Klowen Braces of Richardson, Texas, recalled the KL Owen Custom Orthodontic Solution because a product error defect may cause incorrect bracket placement. The company began the recall on June 8, 2026, and the FDA added it to its Enforcement Report on July 8, 2026. The recall involved 3 units distributed in Ohio, South Carolina, Texas and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number, UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
KL Owen Custom Orthodontic Solution
- Model number
- CIAS-800033
- UDI-DI
- 10850061082029
- 1779407586392
- 1779138889952
- 1778173992342
- Lot code
- 1779407586392-0
- 1779138889952-0
- 1778173992342-0
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Ohio, Texas, South Carolina Virginia.
- Company
- Klowen BracesRichardson, Texas
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99277
- Recall number
- Z-2699-2026
- Quantity recalled
- 3 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
