OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Klowen Braces recalls KL Owen Custom Orthodontic Solution

Recall date · record updated Jul 15, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Klowen Braces
Reason
A product error defect may cause incorrect bracket placement.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of OH, TX, SC VA.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99277…

Products

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

    Codes/lots: UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0Quantity: 3 unitsRecall no. Z-2699-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls