Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF… — Class II medical device recall Z-1017-2023
Completed recall by Align Technology Inc, reported 2023-02-01, distributed nationwide. 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be
| Recall number | Z-1017-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Align Technology Inc, San Jose, CA, United States |
| Recall initiated | 2022-12-05 |
| Classified | 2023-01-26 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Model numbers | 8512, 9000, 9001 |
Product
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1017-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.