Consumer Alerts TrackerIndependent U.S. recall decision aid
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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 15, 2026

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

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

  • Lot Numbers
  • Lot 1779138889952-0
  • Lot 1778173992342-0
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-03 unitsZ-2699-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

A product error defect may cause incorrect bracket placement.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US Nationwide distribution in the states of OH, TX, SC VA.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.