CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report
KL Owen Custom Orthodontic Solution recalled by Klowen Braces
Klowen Braces is recalling KL Owen Custom Orthodontic Solution, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2699-2026
- FDA event ID
- 99277
- Recalling firm
- Klowen Braces, Richardson, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jun 2026
- FDA classified
- 8 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Dental Devices
Timeline
| 8 Jun 2026 | Recall initiated by company | |
| 8 Jul 2026 | Classified by FDA | +30 days |
| 15 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A product error defect may cause incorrect bracket placement.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Where it was distributed
US Nationwide distribution in the states of OH, TX, SC VA.
Questions about this recall
Why was it recalled?
A product error defect may cause incorrect bracket placement.
Which lots are affected?
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Where was it sold?
US Nationwide distribution in the states of OH, TX, SC VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Medline Convenience Kits: Dental Pack recalled by Medline Industries | Medline Industries | Sterility | Nationwide |