Filing Flows › Align Technology (ALGN) › Recalls, complaints & regulation
Align Technology (ALGN): recalls, EPA violations, clinical trials and Federal Register
Align Technology (ALGN) beyond its filings: 0 recalls in the last 12 months (1 in five years, 0 Class I); 1 EPA-regulated facility in violation, $96K in penalties over five years; 3 Federal Register documents in a year; 1 active clinical trial.
Latest recalls
- 2023-02-01 · FDA device · Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
EPA facilities in violation
| Facility (as registered) | City | Status | Penalties |
|---|---|---|---|
| ALIGN PRODUCTION SYSTEMS | Decatur, IL | Violation | — |
Facilities in the EPA's ECHO register whose registered name matches the company's; a facility can belong to another business of the same name.
Align Technology's latest quarter
Align Technology, Q3 2026: revenue $1.0B (+2% year over year), operating margin 16.7%, net earnings $135M, operating cash flow $183M. The chart follows the revenue to costs, profit and cash.
Questions
Has Align Technology had any recalls?
1 recall on file over five years from the FDA, CPSC and NHTSA; 0 in the last 12 months.
Has Align Technology been fined by the EPA?
The 12 EPA-regulated facilities on file under its name drew $96K in penalties over five years; 1 is in violation now.
How many clinical trials does Align Technology have?
1 active study on ClinicalTrials.gov, 0 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.