Stock: HAE. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
36
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
48
0 class I
Adverse event reports
2,013
171 deaths reported
Haemonetics has 48 recalled medical device products in 19 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Apr 26, 2022. In 2020 it had 1 recalled products.
36 510(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 Apr 30, 2025.
2,013 reports in total: 171 deaths, 162 injuries and 1,658 malfunctions were reported. 7 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 |
|---|---|---|---|---|
| 2025 | 2 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 |
| 2019 |
By product code, all years
All device makers and procedures · HAE 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 HAE 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.
| 1 |
| 0 |
| 0 |
| 0 |
| 2017 | 2 | 0 | 0 | 0 |
| 2016 | 1 | 0 | 0 | 0 |
| 2012 | 2 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 2 | 2 |
| 2025 | 0 | 0 | 7 | 3 |
| 2024 | 0 | 0 | 26 | 21 |
| 2023 | 0 | 0 | 34 | 16 |
| 2022 | 2 | 0 | 64 | 21 |
| 2021 | 0 | 0 | 185 | 21 |
| 2020 | 1 | 0 | 171 | 51 |
| 2019 | 22 | 0 | 11 | 2 |
| 2018 | 2 | 0 | 28 | 6 |
| 2017 | 2 | 0 | 29 | 2 |
| 2016 | 0 | 0 | 82 | 1 |
| 2015 | 1 | 0 | 38 | - |
| 2014 | 0 | 0 | 35 | 1 |
| 2013 | 1 | 0 | 79 | 1 |
| 2012 | 0 | 0 | 190 | 1 |