Stock: GEHC. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
1,100
De Novo: 0
PMA approvals
6
66 supplements
Recalled products
1,435
108 class I
Adverse event reports
171K
409 deaths reported
GE HealthCare has 1,435 recalled medical device products in 658 recall actions in the records, 108 of them class I (the most serious kind). The newest recall started on Jul 31, 2026. In 2025 it had 109 recalled products.
1,100 510(k) clearances, 0 De Novo grants and 6 original PMA approvals for high-risk devices, plus 66 PMA supplements (changes to approved devices). The newest decision was on Sep 16, 2026.
170,877 reports in total: 409 deaths, 2,107 injuries and 167,703 malfunctions were reported. 14,600 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 | 27 | 0 | 0 | 0 |
| 2025 | 27 | 0 | 0 | 2 |
| 2024 | 21 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · GEHC 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 GEHC 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.
| 28 |
| 0 |
| 0 |
| 0 |
| 2022 | 38 | 0 | 1 | 0 |
| 2021 | 27 | 0 | 0 | 1 |
| 2020 | 36 | 0 | 0 | 0 |
| 2019 | 20 | 0 | 0 | 0 |
| 2018 | 30 | 0 | 0 | 2 |
| 2017 | 29 | 0 | 0 | 5 |
| 2016 | 33 | 0 | 0 | 0 |
| 2015 | 29 | 0 | 0 | 2 |
| 2014 | 29 | 0 | 1 | 3 |
| 2013 | 40 | 0 | 0 | 1 |
| 2012 | 37 | 0 | 1 | 1 |
| 2011 | 7 | 0 | 0 | 1 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 53 | 3 | 7,775 | 4 |
| 2025 | 109 | 18 | 14,600 | 8 |
| 2024 | 113 | 13 | 9,664 | 5 |
| 2023 | 45 | 20 | 8,629 | 10 |
| 2022 | 45 | 9 | 6,895 | 5 |
| 2021 | 87 | 0 | 3,399 | 12 |
| 2020 | 40 | 0 | 4,221 | 10 |
| 2019 | 80 | 15 | 3,214 | 19 |
| 2018 | 85 | 4 | 3,098 | 9 |
| 2017 | 42 | 0 | 3,534 | 6 |
| 2016 | 42 | 0 | 6,479 | 13 |
| 2015 | 62 | 1 | 5,744 | 14 |
| 2014 | 54 | 1 | 10,665 | 12 |
| 2013 | 73 | 14 | 14,222 | 10 |
| 2012 | 63 | 4 | 12,316 | 7 |