Align Technology Inc Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Brand
Align Technology Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Invisalign Express 10 Product Code: 8512 SO/PID: 215086492 / 18752002 Invisalign System - Comprehensive Product Code: 9000 SO / PID: 215072477 / 18747673 213766469 / 17291917 215237342 / 16525818 215211007 / 18799320 215234241 / 15985771 215275953 / 18824845 215035759 / 16193974 215038858 / 18715205 215349325 / 18799786 215125907 / 18746963 215541695 / 16576036 215451877 / 14994856 Invisalign System - Moderate Product Code: 9001 SO/PID: 214866511 / 18672529
Align Technology Inc is recalling Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Mode due to 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 doct. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 12/05/2022, the firm initiated telephone calls with customer to inform them of a voluntary recall of selected Invisalign aligners. Starting on 12/09/2022, the firm sent an "URGENT Medical Device Correction" email to customers as a follow-up to a telephone call informing them that selected Invisalign aligners may have the potential clinical impact and therefore may result in unnecessary/unprescribed treatment due to software issue with the new Treatment Planning History feature within ClinCheck software. Customers are instructed: 1. Cease/stop using and dispose of the affected Invisalign case(s), including the aligners and packaging, and treatment PDF form-printed or online 2. Notify patients to discard the impacted aligners, if they have already been provided to them. The impacted product can be discarded as per the Doctor Instructions for Use or Patient Use and Care Instructions. As an immediate action, Align Technology has disabled the ClinCheck feature capability from the Treatment Plan History. For questions - contact CustomerSupport@aligntech.com or 888-822-5446.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026