Stock: SNN. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
792
De Novo: 1
PMA approvals
6
159 supplements
Recalled products
587
0 class I
Adverse event reports
113K
99 deaths reported
Smith & Nephew has 587 recalled medical device products in 175 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Mar 16, 2026. In 2025 it had 2 recalled products.
792 510(k) clearances, 1 De Novo grants and 6 original PMA approvals for high-risk devices, plus 159 PMA supplements (changes to approved devices). The newest decision was on Sep 11, 2026.
112,769 reports in total: 99 deaths, 47,337 injuries and 64,433 malfunctions were reported. 6,460 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 | 5 | 1 | 0 | 0 |
| 2025 | 9 | 0 | 0 | 8 |
| 2024 | 16 | 0 | 0 | 10 |
| 2023 |
By product code, all years
All device makers and procedures · SNN 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 SNN 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.
| 15 |
| 0 |
| 0 |
| 9 |
| 2022 | 17 | 0 | 0 | 16 |
| 2021 | 13 | 0 | 0 | 7 |
| 2020 | 14 | 0 | 0 | 1 |
| 2019 | 13 | 0 | 0 | 3 |
| 2018 | 13 | 0 | 0 | 6 |
| 2017 | 21 | 0 | 0 | 9 |
| 2016 | 16 | 0 | 1 | 10 |
| 2015 | 19 | 0 | 0 | 4 |
| 2014 | 11 | 0 | 0 | 10 |
| 2013 | 19 | 0 | 0 | 4 |
| 2012 | 26 | 0 | 0 | 4 |
| 2011 | 8 | 0 | 0 | 2 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 1 | 0 | 4,537 | 1 |
| 2025 | 2 | 0 | 6,460 | 2 |
| 2024 | 14 | 0 | 6,958 | 1 |
| 2023 | 10 | 0 | 6,645 | 2 |
| 2022 | 4 | 0 | 9,122 | 8 |
| 2021 | 10 | 0 | 17,505 | 7 |
| 2020 | 63 | 0 | 18,046 | 8 |
| 2019 | 8 | 0 | 9,188 | 11 |
| 2018 | 20 | 0 | 6,952 | 7 |
| 2017 | 49 | 0 | 6,121 | 7 |
| 2016 | 35 | 0 | 3,704 | 8 |
| 2015 | 17 | 0 | 3,409 | 6 |
| 2014 | 22 | 0 | 2,048 | 4 |
| 2013 | 46 | 0 | 1,577 | 5 |
| 2012 | 74 | 0 | 1,436 | 2 |