Stock: DHR. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
449
De Novo: 4
PMA approvals
6
196 supplements
Recalled products
790
5 class I
Adverse event reports
56K
25 deaths reported
Danaher has 790 recalled medical device products in 530 recall actions in the records, 5 of them class I (the most serious kind). The newest recall started on Jul 15, 2026. In 2025 it had 58 recalled products.
449 510(k) clearances, 4 De Novo grants and 6 original PMA approvals for high-risk devices, plus 196 PMA supplements (changes to approved devices). The newest decision was on Aug 7, 2026.
56,304 reports in total: 25 deaths, 3,650 injuries and 50,400 malfunctions were reported. 1,018 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 | 13 | 0 | 0 | 1 |
| 2025 | 17 | 0 | 1 | 3 |
| 2024 | 24 | 1 | 0 | 2 |
| 2023 |
By product code, all years
All device makers and procedures · DHR 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 DHR 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.
| 22 |
| 0 |
| 0 |
| 1 |
| 2022 | 7 | 0 | 0 | 5 |
| 2021 | 2 | 0 | 0 | 0 |
| 2020 | 7 | 0 | 0 | 20 |
| 2019 | 14 | 0 | 0 | 13 |
| 2018 | 9 | 0 | 0 | 5 |
| 2017 | 15 | 1 | 0 | 19 |
| 2016 | 10 | 0 | 0 | 3 |
| 2015 | 8 | 0 | 0 | 12 |
| 2014 | 16 | 0 | 0 | 15 |
| 2013 | 14 | 1 | 0 | 24 |
| 2012 | 11 | 0 | 2 | 10 |
| 2011 | 3 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 6 | 0 | 591 | - |
| 2025 | 58 | 0 | 1,018 | 3 |
| 2024 | 38 | 0 | 906 | 2 |
| 2023 | 28 | 0 | 807 | 1 |
| 2022 | 5 | 0 | 977 | 2 |
| 2021 | 19 | 0 | 1,565 | 1 |
| 2020 | 22 | 0 | 1,007 | 2 |
| 2019 | 34 | 0 | 1,467 | - |
| 2018 | 33 | 5 | 1,382 | 1 |
| 2017 | 54 | 0 | 324 | 2 |
| 2016 | 25 | 0 | 1,930 | 1 |
| 2015 | 25 | 0 | 3,342 | - |
| 2014 | 25 | 0 | 4,851 | - |
| 2013 | 28 | 0 | 5,231 | 1 |
| 2012 | 23 | 0 | 7,084 | 1 |