Stock: SOLV. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
553
De Novo: 3
PMA approvals
1
12 supplements
Recalled products
111
1 class I
Adverse event reports
6,497
157 deaths reported
Solventum has 111 recalled medical device products in 70 recall actions in the records, 1 of them class I (the most serious kind). The newest recall started on Apr 22, 2025. In 2024 it had 7 recalled products.
553 510(k) clearances, 3 De Novo grants and 1 original PMA approvals for high-risk devices, plus 12 PMA supplements (changes to approved devices). The newest decision was on Mar 13, 2026.
6,497 reports in total: 157 deaths, 3,592 injuries and 2,491 malfunctions were reported. 268 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 | 2 | 0 | 0 | 0 |
| 2024 | 7 | 1 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · SOLV 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 SOLV 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.
| 3 |
| 0 |
| 0 |
| 0 |
| 2022 | 9 | 0 | 0 | 0 |
| 2021 | 6 | 0 | 0 | 0 |
| 2020 | 11 | 0 | 0 | 0 |
| 2019 | 11 | 1 | 0 | 0 |
| 2018 | 8 | 0 | 0 | 0 |
| 2017 | 9 | 0 | 0 | 0 |
| 2016 | 6 | 0 | 0 | 0 |
| 2015 | 8 | 0 | 0 | 0 |
| 2014 | 2 | 0 | 0 | 0 |
| 2013 | 8 | 0 | 0 | 0 |
| 2012 | 8 | 0 | 0 | 0 |
| 2011 | 1 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 225 | 2 |
| 2025 | 4 | 1 | 268 | 3 |
| 2024 | 7 | 0 | 199 | 2 |
| 2023 | 6 | 0 | 226 | - |
| 2022 | 0 | 0 | 349 | 9 |
| 2021 | 1 | 0 | 450 | 11 |
| 2020 | 6 | 0 | 1,209 | 3 |
| 2019 | 2 | 0 | 627 | 3 |
| 2018 | 6 | 0 | 269 | 11 |
| 2017 | 4 | 0 | 305 | 4 |
| 2016 | 2 | 0 | 254 | 7 |
| 2015 | 3 | 0 | 193 | 4 |
| 2014 | 13 | 0 | 242 | 8 |
| 2013 | 4 | 0 | 221 | 1 |
| 2012 | 4 | 0 | 154 | 5 |