Stock: COO. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
144
De Novo: 0
PMA approvals
14
657 supplements
Recalled products
127
0 class I
Adverse event reports
4,103
15 deaths reported
Cooper Companies has 127 recalled medical device products in 78 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Aug 12, 2026. In 2025 it had 9 recalled products.
144 510(k) clearances, 0 De Novo grants and 14 original PMA approvals for high-risk devices, plus 657 PMA supplements (changes to approved devices). The newest decision was on Sep 2, 2026.
4,103 reports in total: 15 deaths, 1,889 injuries and 2,088 malfunctions were reported. 153 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 | 12 |
| 2025 | 2 | 0 | 0 | 27 |
| 2024 | 1 | 0 | 0 | 26 |
| 2023 |
By product code, all years
All device makers and procedures · COO 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 COO 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.
| 0 |
| 0 |
| 0 |
| 20 |
| 2022 | 2 | 0 | 0 | 28 |
| 2021 | 1 | 0 | 0 | 29 |
| 2020 | 6 | 0 | 0 | 43 |
| 2019 | 5 | 0 | 1 | 29 |
| 2018 | 3 | 0 | 0 | 30 |
| 2017 | 2 | 0 | 1 | 25 |
| 2016 | 2 | 0 | 0 | 11 |
| 2015 | 3 | 0 | 0 | 13 |
| 2014 | 2 | 0 | 0 | 9 |
| 2013 | 3 | 0 | 0 | 17 |
| 2012 | 1 | 0 | 0 | 27 |
| 2011 | 3 | 0 | 0 | 7 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 3 | 0 | 178 | - |
| 2025 | 9 | 0 | 153 | 1 |
| 2024 | 13 | 0 | 202 | - |
| 2023 | 6 | 0 | 273 | - |
| 2022 | 10 | 0 | 362 | - |
| 2021 | 23 | 0 | 340 | 1 |
| 2020 | 6 | 0 | 381 | - |
| 2019 | 12 | 0 | 440 | - |
| 2018 | 8 | 0 | 172 | - |
| 2017 | 3 | 0 | 187 | - |
| 2016 | 3 | 0 | 182 | - |
| 2015 | 14 | 0 | 110 | - |
| 2014 | 6 | 0 | 81 | - |
| 2013 | 4 | 0 | 125 | - |
| 2012 | 0 | 0 | 264 | - |