FDA recall Z-2699-2026

Product

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Reason for recall

A product error defect may cause incorrect bracket placement.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-06-08

Report date

2026-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richardson, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2699-2026