Richardson, TX, United States
Klowen Braces recalls
1 recall recorded since 2018, most recently on 8 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 June 2026
- Reason
- A product error defect may cause incorrect bracket placement.
- Distribution
- US Nationwide distribution in the states of OH, TX, SC VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2699-2026
- KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.