Stock: DXCM. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
25
De Novo: 3
PMA approvals
2
132 supplements
Recalled products
29
16 class I
Adverse event reports
2.5M
355 deaths reported
Dexcom has 29 recalled medical device products in 11 recall actions in the records, 16 of them class I (the most serious kind). The newest recall started on May 27, 2026. In 2025 it had 14 recalled products.
25 510(k) clearances, 3 De Novo grants and 2 original PMA approvals for high-risk devices, plus 132 PMA supplements (changes to approved devices). The newest decision was on Aug 11, 2026.
2,505,815 reports in total: 355 deaths, 32,848 injuries and 2,472,000 malfunctions were reported. 353,934 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 | 5 | 0 | 0 | 0 |
| 2025 | 3 | 0 | 0 | 0 |
| 2024 | 3 | 0 | 0 | 1 |
| 2023 |
By product code, all years
All device makers and procedures · DXCM 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 DXCM 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.
| 2 |
| 0 |
| 0 |
| 1 |
| 2022 | 2 | 0 | 0 | 1 |
| 2021 | 2 | 0 | 0 | 1 |
| 2020 | 2 | 0 | 0 | 2 |
| 2019 | 4 | 0 | 0 | 4 |
| 2018 | 2 | 1 | 0 | 10 |
| 2017 | 0 | 0 | 0 | 12 |
| 2016 | 0 | 0 | 0 | 13 |
| 2015 | 0 | 1 | 0 | 11 |
| 2014 | 0 | 1 | 0 | 19 |
| 2013 | 0 | 0 | 0 | 11 |
| 2012 | 0 | 0 | 1 | 9 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 4 | 0 | 237,616 | 41 |
| 2025 | 14 | 10 | 353,934 | 32 |
| 2024 | 0 | 0 | 340,691 | 24 |
| 2023 | 0 | 0 | 272,849 | 8 |
| 2022 | 0 | 0 | 233,481 | 7 |
| 2021 | 0 | 0 | 260,612 | 3 |
| 2020 | 3 | 0 | 213,858 | 8 |
| 2019 | 2 | 0 | 131,730 | 7 |
| 2018 | 0 | 0 | 169,992 | 9 |
| 2017 | 0 | 0 | 116,791 | 28 |
| 2016 | 6 | 6 | 96,846 | 106 |
| 2015 | 0 | 0 | 41,091 | 71 |
| 2014 | 0 | 0 | 34,889 | 6 |
| 2013 | 0 | 0 | 482 | 1 |
| 2012 | 0 | 0 | 355 | 4 |