Stock: ABT. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
1,679
De Novo: 3
PMA approvals
118
6,462 supplements
Recalled products
1,199
108 class I
Adverse event reports
1.7M
36,556 deaths reported
Abbott has 1,199 recalled medical device products in 620 recall actions in the records, 108 of them class I (the most serious kind). The newest recall started on Aug 20, 2026. In 2025 it had 44 recalled products.
1,679 510(k) clearances, 3 De Novo grants and 118 original PMA approvals for high-risk devices, plus 6,462 PMA supplements (changes to approved devices). The newest decision was on Sep 18, 2026.
1,736,543 reports in total: 36,556 deaths, 680,204 injuries and 1,015,526 malfunctions were reported. 134,189 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 | 14 | 1 | 0 | 214 |
| 2025 | 29 | 0 | 2 | 265 |
| 2024 | 16 | 0 | 2 | 293 |
| 2023 |
By product code, all years
All device makers and procedures · ABT 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 ABT 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.
| 34 |
| 0 |
| 2 |
| 271 |
| 2022 | 30 | 0 | 3 | 166 |
| 2021 | 20 | 0 | 2 | 238 |
| 2020 | 20 | 0 | 2 | 259 |
| 2019 | 18 | 1 | 1 | 221 |
| 2018 | 18 | 0 | 1 | 329 |
| 2017 | 20 | 0 | 5 | 288 |
| 2016 | 23 | 0 | 5 | 258 |
| 2015 | 26 | 0 | 1 | 198 |
| 2014 | 21 | 0 | 3 | 252 |
| 2013 | 25 | 1 | 3 | 206 |
| 2012 | 27 | 0 | 5 | 340 |
| 2011 | 8 | 0 | 1 | 80 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 12 | 0 | 363,243 | 1,735 |
| 2025 | 44 | 12 | 134,189 | 3,012 |
| 2024 | 55 | 7 | 134,343 | 2,485 |
| 2023 | 33 | 11 | 146,293 | 3,967 |
| 2022 | 39 | 1 | 129,308 | 2,115 |
| 2021 | 30 | 8 | 170,932 | 2,121 |
| 2020 | 38 | 17 | 83,110 | 2,665 |
| 2019 | 52 | 7 | 76,099 | 2,497 |
| 2018 | 50 | 1 | 69,144 | 2,472 |
| 2017 | 45 | 9 | 66,806 | 3,024 |
| 2016 | 28 | 13 | 53,207 | 1,915 |
| 2015 | 12 | 2 | 41,380 | 1,806 |
| 2014 | 32 | 11 | 55,187 | 1,983 |
| 2013 | 19 | 4 | 41,553 | 1,185 |
| 2012 | 39 | 5 | 30,765 | 748 |