Stock: MMSI. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
194
De Novo: 0
PMA approvals
1
4 supplements
Recalled products
300
7 class I
Adverse event reports
8,875
79 deaths reported
Merit Medical Systems has 300 recalled medical device products in 93 recall actions in the records, 7 of them class I (the most serious kind). The newest recall started on Aug 10, 2026. In 2025 it had 16 recalled products.
194 510(k) clearances, 0 De Novo grants and 1 original PMA approvals for high-risk devices, plus 4 PMA supplements (changes to approved devices). The newest decision was on Jul 27, 2026.
8,875 reports in total: 79 deaths, 2,154 injuries and 6,573 malfunctions were reported. 901 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 | 8 | 0 | 0 | 1 |
| 2025 | 8 | 0 | 0 | 3 |
| 2024 | 4 | 0 | 1 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · MMSI 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 MMSI 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.
| 8 |
| 0 |
| 0 |
| 0 |
| 2022 | 4 | 0 | 0 | 0 |
| 2021 | 7 | 0 | 0 | 0 |
| 2020 | 7 | 0 | 0 | 0 |
| 2019 | 5 | 0 | 0 | 0 |
| 2018 | 8 | 0 | 0 | 0 |
| 2017 | 13 | 0 | 0 | 0 |
| 2016 | 7 | 0 | 0 | 0 |
| 2015 | 8 | 0 | 0 | 0 |
| 2014 | 13 | 0 | 0 | 0 |
| 2013 | 10 | 0 | 0 | 0 |
| 2012 | 7 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 10 | 5 | 863 | 7 |
| 2025 | 16 | 0 | 901 | 11 |
| 2024 | 44 | 0 | 406 | 8 |
| 2023 | 18 | 0 | 386 | 5 |
| 2022 | 4 | 0 | 585 | 6 |
| 2021 | 6 | 0 | 333 | 6 |
| 2020 | 9 | 0 | 328 | 1 |
| 2019 | 1 | 0 | 421 | 4 |
| 2018 | 4 | 0 | 428 | 6 |
| 2017 | 8 | 1 | 410 | 2 |
| 2016 | 9 | 0 | 399 | 2 |
| 2015 | 2 | 0 | 365 | 4 |
| 2014 | 5 | 0 | 351 | 3 |
| 2013 | 6 | 1 | 356 | 2 |
| 2012 | 3 | 0 | 342 | 1 |