Stock: TMO. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
167
De Novo: 2
PMA approvals
3
114 supplements
Recalled products
49
0 class I
Adverse event reports
1,476
151 deaths reported
Thermo Fisher Scientific has 49 recalled medical device products in 23 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Feb 1, 2026. In 2024 it had 1 recalled products.
167 510(k) clearances, 2 De Novo grants and 3 original PMA approvals for high-risk devices, plus 114 PMA supplements (changes to approved devices). The newest decision was on Sep 9, 2026.
1,476 reports in total: 151 deaths, 681 injuries and 600 malfunctions were reported. 54 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 | 6 |
| 2025 | 13 | 0 | 1 | 11 |
| 2024 | 8 | 0 | 0 | 5 |
| 2023 |
By product code, all years
All device makers and procedures · TMO 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 TMO 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.
| 12 |
| 1 |
| 0 |
| 8 |
| 2022 | 3 | 0 | 0 | 7 |
| 2021 | 5 | 0 | 0 | 6 |
| 2020 | 4 | 0 | 0 | 6 |
| 2019 | 6 | 0 | 0 | 7 |
| 2018 | 3 | 0 | 0 | 7 |
| 2017 | 5 | 0 | 1 | 6 |
| 2016 | 0 | 0 | 0 | 4 |
| 2015 | 9 | 0 | 0 | 6 |
| 2014 | 10 | 0 | 0 | 3 |
| 2013 | 4 | 0 | 0 | 3 |
| 2012 | 2 | 0 | 0 | 6 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 1 | 0 | 29 | 3 |
| 2025 | 0 | 0 | 54 | 7 |
| 2024 | 1 | 0 | 80 | 19 |
| 2023 | 0 | 0 | 44 | 3 |
| 2022 | 0 | 0 | 59 | 10 |
| 2021 | 1 | 0 | 76 | 6 |
| 2020 | 7 | 0 | 100 | 15 |
| 2019 | 17 | 0 | 73 | 6 |
| 2018 | 13 | 0 | 183 | 31 |
| 2017 | 1 | 0 | 93 | 22 |
| 2016 | 1 | 0 | 85 | 13 |
| 2015 | 0 | 0 | 59 | 5 |
| 2014 | 0 | 0 | 236 | - |
| 2013 | 1 | 0 | 206 | 3 |
| 2012 | 1 | 0 | 28 | 2 |