Align Technology, Inc.
1 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (1)
Registered facilities (6)
- Aligntech de Mexico S, de R. L. de C. V. FEI 3007527669 · MX
- Align Technology de Costa Rica S.R.L FEI 3005695824 · CR
- Aligntech de Mexico S, de R. L. de C. V. FEI 3012138716 · MX
- Align Technology, Inc. FEI 3002519584 · CA
- Align Technology, Ltd. FEI 3009646999 · IL
- Align Technology AFAB Poland Sp. z o.o. FEI 3025237243 · PL
Recalls & enforcement
- Class IICompleted2022-12-053D 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.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Align Technology, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9035576-align-technology-inc/
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