Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Recalled by Align Technology Inc Due to 3D orthodontic planning software has a defect that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Align Technology Inc directly.
Affected Products
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Quantity: 14 cases (637 aligner and temples)
Why Was This Recalled?
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Align Technology Inc
Align Technology Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report