The Recall Desk

Manufacturer

Align Technology Inc

1 recall in our database name Align Technology Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2023-02-01

Of the 1 recalls from Align Technology Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-1017-2023·2023-02-01

    Invisalign Orthodontic Aligners Recalled for Software Defect Causing Incorrect Quantities

    Align Technology is recalling Invisalign Express 10, Comprehensive, and Moderate systems due to a software defect that may produce incorrect numbers of aligners and incorrect packaging.

    Product
    Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Align Technology

company in San Jose, United States

Country
United States
Founded
1997

Official website

Source: Wikidata (Q30272258), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.