Class II

Medical Device Recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Klowen Braces · June 8, 2026

Reason for Recall

A product error defect may cause incorrect bracket placement.

Distribution

US Nationwide distribution in the states of OH, TX, SC VA.

States Affected

NATIONWIDE

Quantity Affected

3 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2699-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.