Braces Recall: Klowen CIAS-800033
Announced 2026-07-15 · FDA
FDA announced a recall of the KL Owen Custom Orthodontic Solution, model CIAS-800033, due to a product error defect that may cause incorrect bracket placement. Three units were distributed nationwide across Ohio, Texas, South Carolina, and Virginia. The recall references UDI/DI 10850061082029 and lot numbers 1779407586392-0, 1779138889952-0, 1778173992342-0; no corrective action is provided.
| Brand | Klowen Braces |
|---|---|
| Product | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, |
| Reason | A product error defect may cause incorrect bracket placement. |
| Severity | moderate |
| Units affected | 3 |
| Distribution | US Nationwide distribution in the states of OH, TX, SC VA. |
| Agency | FDA |
| Recall / campaign no. | UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0 |
WHAT YOU SHOULD DO
- If you own this device, stop using it and consult your orthodontist or supplier for guidance.
- Check your device's UDI/DI and lot numbers against the recall numbers to determine if your unit is affected.
- Contact the seller or manufacturer for replacement, return, or disposal instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.