Data Foundry

Medical device recalls 2026

KL Owen Custom Orthodontic Solution — Class II medical device recall Z-2699-2026

Ongoing recall by Klowen Braces, reported 2026-07-15, distributed nationwide. A product error defect may cause incorrect bracket placement.

Recall numberZ-2699-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmKlowen Braces, Richardson, TX, United States
Recall initiated2026-06-08
Classified2026-07-08
Reported by FDA2026-07-15
DistributedNationwide (US)
Quantity3 units
UPC / GTIN / UDI-DI10850061082029
Lot numbers1778173992342-0, 1779138889952-0, 1779407586392-0
Model numbersCIAS-800033

Product

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

Reason for recall

A product error defect may cause incorrect bracket placement.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2699-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.