FDA Device recall Z-2699-2026
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033 by Klowen Braces, citing A product error defect may cause incorrect bracket placement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2699-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-08 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Klowen Braces |
| Distribution | US |
Product
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Reason
A product error defect may cause incorrect bracket placement.
Identifiers
| code_info | UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2699-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.