Stock: FMS. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
112
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
209
19 class I
Adverse event reports
40K
24,909 deaths reported
Fresenius Medical Care has 209 recalled medical device products in 96 recall actions in the records, 19 of them class I (the most serious kind). The newest recall started on Aug 10, 2026. In 2025 it had 3 recalled products.
112 510(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 Jul 24, 2026.
39,616 reports in total: 24,909 deaths, 9,228 injuries and 5,290 malfunctions were reported. 52 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 | 4 | 0 | 0 | 0 |
| 2025 | 12 | 0 | 0 | 0 |
| 2024 | 5 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · FMS 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 FMS 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.
| 4 |
| 0 |
| 0 |
| 0 |
| 2022 | 6 | 0 | 0 | 0 |
| 2020 | 8 | 0 | 0 | 0 |
| 2019 | 2 | 0 | 0 | 0 |
| 2018 | 6 | 0 | 0 | 0 |
| 2017 | 4 | 0 | 0 | 0 |
| 2016 | 2 | 0 | 0 | 0 |
| 2015 | 4 | 0 | 0 | 0 |
| 2014 | 4 | 0 | 0 | 0 |
| 2013 | 5 | 0 | 0 | 0 |
| 2012 | 5 | 0 | 0 | 0 |
| 2011 | 3 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 12 | 0 | 62 | - |
| 2025 | 3 | 0 | 52 | 2 |
| 2024 | 22 | 5 | 31 | 4 |
| 2023 | 13 | 11 | 39 | - |
| 2022 | 10 | 0 | 41 | 4 |
| 2021 | 12 | 0 | 28 | 1 |
| 2020 | 36 | 0 | 32 | 6 |
| 2019 | 2 | 0 | 10 | 4 |
| 2018 | 8 | 0 | 6 | 2 |
| 2017 | 3 | 0 | 14 | 10 |
| 2016 | 8 | 0 | 2,363 | 293 |
| 2015 | 11 | 0 | 11,148 | 7,578 |
| 2014 | 22 | 1 | 20,126 | 14,017 |
| 2013 | 9 | 0 | 4,825 | 2,890 |
| 2012 | 15 | 2 | 114 | 51 |