Stock: ENOV. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
102
De Novo: 0
PMA approvals
4
50 supplements
Recalled products
201
2 class I
Adverse event reports
23K
6 deaths reported
Enovis has 201 recalled medical device products in 103 recall actions in the records, 2 of them class I (the most serious kind). The newest recall started on Mar 19, 2026. In 2025 it had 15 recalled products.
102 510(k) clearances, 0 De Novo grants and 4 original PMA approvals for high-risk devices, plus 50 PMA supplements (changes to approved devices). The newest decision was on Jan 15, 2026.
23,076 reports in total: 6 deaths, 17,868 injuries and 1,277 malfunctions were reported. 2,230 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 | 7 | 0 | 1 | 0 |
| 2024 | 2 | 0 | 0 | 1 |
| 2023 |
By product code, all years
All device makers and procedures · ENOV 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 ENOV 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.
| 4 |
| 0 |
| 0 |
| 1 |
| 2022 | 3 | 0 | 0 | 4 |
| 2021 | 2 | 0 | 0 | 5 |
| 2020 | 3 | 0 | 0 | 3 |
| 2019 | 3 | 0 | 0 | 2 |
| 2018 | 2 | 0 | 0 | 2 |
| 2017 | 8 | 0 | 0 | 0 |
| 2016 | 7 | 0 | 0 | 3 |
| 2015 | 2 | 0 | 0 | 1 |
| 2014 | 7 | 0 | 0 | 2 |
| 2013 | 7 | 0 | 0 | 2 |
| 2012 | 7 | 0 | 0 | 1 |
| 2011 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 11 | 0 | 1,788 | - |
| 2025 | 15 | 0 | 2,230 | - |
| 2024 | 2 | 0 | 2,219 | 1 |
| 2023 | 16 | 0 | 1,971 | - |
| 2022 | 4 | 0 | 1,823 | - |
| 2021 | 6 | 2 | 1,568 | - |
| 2020 | 7 | 0 | 1,315 | - |
| 2019 | 3 | 0 | 1,435 | - |
| 2018 | 12 | 0 | 914 | - |
| 2017 | 17 | 0 | 1,048 | - |
| 2016 | 5 | 0 | 525 | - |
| 2015 | 7 | 0 | 840 | - |
| 2014 | 1 | 0 | 871 | - |
| 2013 | 2 | 0 | 735 | - |
| 2012 | 3 | 0 | 716 | 1 |