Stock: HOLX. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
127
De Novo: 2
PMA approvals
18
327 supplements
Recalled products
73
2 class I
Adverse event reports
11K
60 deaths reported
Hologic has 73 recalled medical device products in 53 recall actions in the records, 2 of them class I (the most serious kind). The newest recall started on Apr 8, 2026. In 2025 it had 4 recalled products.
127 510(k) clearances, 2 De Novo grants and 18 original PMA approvals for high-risk devices, plus 327 PMA supplements (changes to approved devices). The newest decision was on Sep 2, 2026.
10,681 reports in total: 60 deaths, 5,563 injuries and 4,674 malfunctions were reported. 1,188 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 | 3 | 0 | 0 | 3 |
| 2025 | 5 | 0 | 0 | 4 |
| 2024 | 6 | 1 | 0 | 10 |
| 2023 |
By product code, all years
All device makers and procedures · HOLX 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 HOLX 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.
| 5 |
| 0 |
| 0 |
| 5 |
| 2022 | 2 | 0 | 1 | 10 |
| 2021 | 0 | 0 | 0 | 8 |
| 2020 | 4 | 0 | 0 | 15 |
| 2019 | 7 | 1 | 0 | 20 |
| 2018 | 6 | 0 | 1 | 30 |
| 2017 | 7 | 0 | 1 | 4 |
| 2016 | 2 | 0 | 0 | 5 |
| 2015 | 4 | 0 | 0 | 10 |
| 2014 | 3 | 0 | 0 | 26 |
| 2013 | 8 | 0 | 0 | 13 |
| 2012 | 9 | 0 | 0 | 14 |
| 2011 | 0 | 0 | 0 | 3 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 4 | 0 | 914 | - |
| 2025 | 4 | 0 | 1,188 | 11 |
| 2024 | 6 | 2 | 879 | 6 |
| 2023 | 4 | 0 | 650 | 13 |
| 2022 | 4 | 0 | 1,345 | 1 |
| 2021 | 1 | 0 | 616 | 7 |
| 2020 | 2 | 0 | 339 | 3 |
| 2019 | 1 | 0 | 514 | 3 |
| 2018 | 2 | 0 | 507 | 3 |
| 2017 | 5 | 0 | 660 | - |
| 2016 | 7 | 0 | 409 | 5 |
| 2015 | 0 | 0 | 309 | 2 |
| 2014 | 3 | 0 | 301 | 1 |
| 2013 | 3 | 0 | 303 | 2 |
| 2012 | 3 | 0 | 367 | 1 |