Stock: ALGN. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
16
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
1
0 class I
Adverse event reports
1,014
- deaths reported
Align Technology has 1 recalled medical device products in 1 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Dec 5, 2022. In 2022 it had 1 recalled products.
16 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Jul 2, 2026.
1,014 reports in total: - deaths, 915 injuries and 20 malfunctions were reported. 154 reports were received in 2025. A report alone does not show that the device caused the problem.
Last 15 years
| Year | 510(k) clearance | De Novo grant | PMA approval | PMA supplement |
|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 |
| 2025 | 3 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · ALGN stock page
Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ALGN with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.
| 2 |
| 0 |
| 0 |
| 0 |
| 2022 | 2 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 |
| 2015 | 1 | 0 | 0 | 0 |
| 2013 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 98 | - |
| 2025 | 0 | 0 | 154 | - |
| 2024 | 0 | 0 | 95 | - |
| 2023 | 0 | 0 | 74 | - |
| 2022 | 1 | 0 | 56 | - |
| 2021 | 0 | 0 | 46 | - |
| 2020 | 0 | 0 | 85 | - |
| 2019 | 0 | 0 | 123 | - |
| 2018 | 0 | 0 | 62 | - |
| 2017 | 0 | 0 | 39 | - |
| 2016 | 0 | 0 | 32 | - |
| 2015 | 0 | 0 | 30 | - |
| 2014 | 0 | 0 | 18 | - |
| 2013 | 0 | 0 | 16 | - |
| 2012 | 0 | 0 | 16 | - |