Stock: ILMN. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
4
De Novo: 2
PMA approvals
2
33 supplements
Recalled products
9
0 class I
Adverse event reports
7
- deaths reported
Illumina has 9 recalled medical device products in 7 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Oct 28, 2025. In 2023 it had 2 recalled products.
4 510(k) clearances, 2 De Novo grants and 2 original PMA approvals for high-risk devices, plus 33 PMA supplements (changes to approved devices). The newest decision was on Sep 4, 2026.
7 reports in total: - deaths, 4 injuries and 3 malfunctions were reported. 1 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 | 0 | 0 | 0 | 4 |
| 2025 | 0 | 0 | 0 | 3 |
| 2024 | 0 | 0 | 1 | 1 |
| 2023 |
By product code, all years
All device makers and procedures · ILMN 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 ILMN 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.
| 0 |
| 0 |
| 0 |
| 2 |
| 2022 | 0 | 0 | 0 | 3 |
| 2021 | 0 | 0 | 0 | 2 |
| 2020 | 0 | 0 | 0 | 4 |
| 2019 | 0 | 0 | 0 | 8 |
| 2018 | 0 | 0 | 0 | 6 |
| 2017 | 0 | 0 | 1 | 0 |
| 2013 | 2 | 2 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 1 | - |
| 2025 | 1 | 0 | 1 | - |
| 2024 | 0 | 0 | 1 | - |
| 2023 | 2 | 0 | 1 | - |
| 2022 | 3 | 0 | 1 | - |
| 2021 | 0 | 0 | 1 | - |
| 2017 | 0 | 0 | 1 | - |