Stock: ISRG. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
198
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
277
1 class I
Adverse event reports
149K
940 deaths reported
Intuitive Surgical has 277 recalled medical device products in 122 recall actions in the records, 1 of them class I (the most serious kind). The newest recall started on Apr 24, 2026. In 2025 it had 13 recalled products.
198 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Sep 8, 2026.
148,554 reports in total: 940 deaths, 14,558 injuries and 131,748 malfunctions were reported. 50,519 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 | 9 | 0 | 0 | 0 |
| 2025 | 21 | 0 | 0 | 0 |
| 2024 | 16 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · ISRG 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 ISRG 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.
| 7 |
| 0 |
| 0 |
| 0 |
| 2022 | 7 | 0 | 0 | 0 |
| 2021 | 9 | 0 | 0 | 0 |
| 2020 | 9 | 0 | 0 | 0 |
| 2019 | 10 | 0 | 0 | 0 |
| 2018 | 13 | 0 | 0 | 0 |
| 2017 | 16 | 0 | 0 | 0 |
| 2016 | 9 | 0 | 0 | 0 |
| 2015 | 6 | 0 | 0 | 0 |
| 2014 | 13 | 0 | 0 | 0 |
| 2013 | 5 | 0 | 0 | 0 |
| 2012 | 4 | 0 | 0 | 0 |
| 2011 | 3 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 4 | 1 | 37,703 | 92 |
| 2025 | 13 | 0 | 50,519 | 138 |
| 2024 | 42 | 0 | 13,970 | 115 |
| 2023 | 4 | 0 | 12,229 | 96 |
| 2022 | 8 | 0 | 6,526 | 112 |
| 2021 | 4 | 0 | 2,090 | 42 |
| 2020 | 3 | 0 | 1,650 | 39 |
| 2019 | 13 | 0 | 1,213 | 17 |
| 2018 | 13 | 0 | 1,118 | 13 |
| 2017 | 19 | 0 | 1,075 | 14 |
| 2016 | 13 | 0 | 1,086 | 15 |
| 2015 | 38 | 0 | 1,703 | 34 |
| 2014 | 49 | 0 | 6,126 | 72 |
| 2013 | 19 | 0 | 6,225 | 59 |
| 2012 | 9 | 0 | 1,587 | 31 |