Stock: SYK. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
1,691
De Novo: 2
PMA approvals
12
252 supplements
Recalled products
2,728
17 class I
Adverse event reports
341K
1,717 deaths reported
Stryker has 2,728 recalled medical device products in 830 recall actions in the records, 17 of them class I (the most serious kind). The newest recall started on Aug 19, 2026. In 2025 it had 57 recalled products.
1,691 510(k) clearances, 2 De Novo grants and 12 original PMA approvals for high-risk devices, plus 252 PMA supplements (changes to approved devices). The newest decision was on Sep 18, 2026.
341,000 reports in total: 1,717 deaths, 105,984 injuries and 230,508 malfunctions were reported. 17,487 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 | 36 | 1 | 0 | 14 |
| 2025 | 38 | 0 | 0 | 23 |
| 2024 | 46 | 0 | 0 | 28 |
| 2023 |
By product code, all years
All device makers and procedures · SYK 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 SYK 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.
| 56 |
| 0 |
| 0 |
| 24 |
| 2022 | 48 | 1 | 0 | 17 |
| 2021 | 37 | 0 | 0 | 22 |
| 2020 | 55 | 0 | 0 | 29 |
| 2019 | 58 | 0 | 1 | 14 |
| 2018 | 54 | 0 | 3 | 8 |
| 2017 | 60 | 0 | 1 | 2 |
| 2016 | 49 | 0 | 0 | 3 |
| 2015 | 72 | 0 | 1 | 4 |
| 2014 | 63 | 0 | 0 | 4 |
| 2013 | 65 | 0 | 0 | 2 |
| 2012 | 65 | 0 | 0 | 6 |
| 2011 | 11 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 69 | 0 | 11,107 | 48 |
| 2025 | 57 | 0 | 17,487 | 47 |
| 2024 | 85 | 1 | 17,146 | 68 |
| 2023 | 149 | 0 | 14,767 | 81 |
| 2022 | 31 | 0 | 13,831 | 72 |
| 2021 | 52 | 0 | 14,556 | 68 |
| 2020 | 82 | 1 | 16,534 | 100 |
| 2019 | 57 | 2 | 18,763 | 97 |
| 2018 | 120 | 0 | 17,415 | 121 |
| 2017 | 124 | 5 | 14,523 | 75 |
| 2016 | 136 | 1 | 15,060 | 75 |
| 2015 | 87 | 1 | 17,722 | 89 |
| 2014 | 293 | 0 | 20,310 | 63 |
| 2013 | 103 | 1 | 30,283 | 85 |
| 2012 | 92 | 5 | 28,541 | 35 |