Align Technology de Costa Rica S.R.L
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Plier, OrthodonticProduct code JEX (opens in a new tab) · Class I · Dental · 21 CFR 872.4565
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.
Related
- All facilities operated by Align Technology, Inc.
- Aligntech de Mexico S, de R. L. de C. V. (MX)
- Aligntech de Mexico S, de R. L. de C. V. (MX)
- Align Technology, Inc. (CA)
- Align Technology, Ltd. (IL)
- Align Technology AFAB Poland Sp. z o.o. (PL)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Align Technology de Costa Rica S.R.L (FEI 3005695824) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005695824-align-technology-de-costa-rica-s-r-l/
Alerts for Align Technology de Costa Rica S.R.L
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.