Stock: IART. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
302
De Novo: 1
PMA approvals
7
494 supplements
Recalled products
463
25 class I
Adverse event reports
27K
228 deaths reported
Integra LifeSciences has 463 recalled medical device products in 182 recall actions in the records, 25 of them class I (the most serious kind). The newest recall started on Jun 5, 2026. In 2025 it had 22 recalled products.
302 510(k) clearances, 1 De Novo grants and 7 original PMA approvals for high-risk devices, plus 494 PMA supplements (changes to approved devices). The newest decision was on Sep 18, 2026.
27,272 reports in total: 228 deaths, 13,756 injuries and 12,864 malfunctions were reported. 994 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 | 2 | 0 | 0 | 13 |
| 2025 | 4 | 0 | 0 | 10 |
| 2024 | 3 | 0 | 0 | 17 |
| 2023 |
By product code, all years
All device makers and procedures · IART 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 IART 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.
| 5 |
| 0 |
| 0 |
| 27 |
| 2022 | 4 | 0 | 0 | 20 |
| 2021 | 3 | 0 | 0 | 28 |
| 2020 | 7 | 0 | 0 | 15 |
| 2019 | 9 | 0 | 0 | 37 |
| 2018 | 10 | 0 | 0 | 28 |
| 2017 | 12 | 0 | 0 | 20 |
| 2016 | 11 | 1 | 0 | 28 |
| 2015 | 8 | 0 | 0 | 29 |
| 2014 | 14 | 0 | 0 | 48 |
| 2013 | 5 | 0 | 0 | 37 |
| 2012 | 13 | 0 | 0 | 13 |
| 2011 | 3 | 0 | 0 | 1 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 11 | 0 | 519 | 2 |
| 2025 | 22 | 8 | 994 | 4 |
| 2024 | 45 | 0 | 1,192 | 3 |
| 2023 | 12 | 1 | 1,116 | 8 |
| 2022 | 5 | 1 | 1,378 | 15 |
| 2021 | 3 | 0 | 1,678 | 9 |
| 2020 | 7 | 0 | 1,950 | 12 |
| 2019 | 79 | 3 | 1,945 | 14 |
| 2018 | 5 | 0 | 1,734 | 22 |
| 2017 | 6 | 0 | 1,722 | 20 |
| 2016 | 20 | 0 | 1,741 | 19 |
| 2015 | 13 | 0 | 1,976 | 22 |
| 2014 | 26 | 0 | 1,731 | 23 |
| 2013 | 95 | 12 | 1,196 | 12 |
| 2012 | 13 | 0 | 1,148 | 8 |