Klow: KL Owen Custom Orthodontic Solution Recall - Incorrect Bracket Placement Risk
Klowen Braces recalls KL Owen Custom Orthodontic Solution model CIAS-800033 due to potential incorrect bracket placement. Affected units include specific lot numbers and UDI/DI codes.
Lower-risk recall
A product error defect may cause incorrect bracket placement.
Contact the company
What happened, in plain English
Klowen Braces is recalling their KL Owen Custom Orthodontic Solution model CIAS-800033 because a manufacturing error might cause incorrect bracket placement. This could lead to improper tooth alignment or discomfort for users. Read more at govinfonow.com/recall/49033-klow-kl-owen-custom-orthodontic-solution-recall-incorrect-bracket-placement.
Source Summary by GovInfoNow · govinfonow.com/recall/49033-klow-kl-owen-custom-orthodontic-solution-recall-incorrect-bracket-placement · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2699-2026
Cite this page
“Klow: KL Owen Custom Orthodontic Solution Recall - Incorrect Bracket Placement Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49033-klow-kl-owen-custom-orthodontic-solution-recall-incorrect-bracket-placement. Based on FDA recall #Z-2699-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2699-2026%22&limit=1).
Why it’s dangerous
A manufacturing error in the product can cause brackets to be placed incorrectly on teeth. This might result in improper tooth alignment or discomfort during treatment.
Who’s affected
Orthodontic patients who own the KL Owen Custom Orthodontic Solution model CIAS-800033 with the listed lot numbers or UDI/DI codes are affected. Patients using the product for dental treatment are most at risk.
How to tell if you have this one
Check for the model number CIAS-800033 on the product. Look for the specific lot numbers: 1779407586392-0, 1779138889952-0, or 1778173992342-0. The UDI/DI code 10850061082029 is also associated with this recall.
- Brand
Klowen Braces- Category
Medical device
What to do — step by step
Check Product Details
Verify the model number CIAS-800033 and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide distribution in the states of OH, TX, SC VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Ohio, South Carolina, Texas, Virginia.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2699-2026 (June 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2699-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.