Stock: BAX. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
1,139
De Novo: 1
PMA approvals
7
189 supplements
Recalled products
1,015
83 class I
Adverse event reports
651K
6,338 deaths reported
Baxter has 1,015 recalled medical device products in 474 recall actions in the records, 83 of them class I (the most serious kind). The newest recall started on Aug 18, 2026. In 2025 it had 63 recalled products.
1,139 510(k) clearances, 1 De Novo grants and 7 original PMA approvals for high-risk devices, plus 189 PMA supplements (changes to approved devices). The newest decision was on Aug 13, 2026.
650,890 reports in total: 6,338 deaths, 66,646 injuries and 573,999 malfunctions were reported. 14,264 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 | 7 | 0 | 0 | 9 |
| 2024 | 7 | 0 | 0 | 10 |
| 2023 |
By product code, all years
All device makers and procedures · BAX 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 BAX 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 |
| 1 |
| 6 |
| 2022 | 11 | 0 | 0 | 4 |
| 2021 | 8 | 0 | 0 | 8 |
| 2020 | 9 | 1 | 0 | 12 |
| 2019 | 8 | 0 | 0 | 8 |
| 2018 | 7 | 0 | 0 | 5 |
| 2017 | 6 | 0 | 0 | 15 |
| 2016 | 3 | 0 | 0 | 5 |
| 2015 | 6 | 0 | 0 | 5 |
| 2014 | 9 | 0 | 0 | 3 |
| 2013 | 9 | 0 | 1 | 7 |
| 2012 | 11 | 0 | 0 | 5 |
| 2011 | 3 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 16 | 6 | 7,704 | 11 |
| 2025 | 63 | 13 | 14,264 | 25 |
| 2024 | 83 | 23 | 16,578 | 85 |
| 2023 | 39 | 9 | 16,164 | 90 |
| 2022 | 74 | 9 | 15,690 | 64 |
| 2021 | 35 | 4 | 15,100 | 80 |
| 2020 | 50 | 5 | 15,458 | 80 |
| 2019 | 14 | 0 | 13,846 | 68 |
| 2018 | 31 | 0 | 14,001 | 58 |
| 2017 | 13 | 0 | 15,038 | 126 |
| 2016 | 22 | 1 | 24,356 | 160 |
| 2015 | 15 | 0 | 58,788 | 1,240 |
| 2014 | 42 | 4 | 128,680 | 2,084 |
| 2013 | 42 | 0 | 65,529 | 440 |
| 2012 | 16 | 8 | 48,715 | 200 |