Stock: JNJ. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
2,423
De Novo: 2
PMA approvals
47
2,793 supplements
Recalled products
1,815
79 class I
Adverse event reports
1.3M
10,113 deaths reported
Johnson & Johnson has 1,815 recalled medical device products in 552 recall actions in the records, 79 of them class I (the most serious kind). The newest recall started on Aug 12, 2026. In 2025 it had 20 recalled products.
2,423 510(k) clearances, 2 De Novo grants and 47 original PMA approvals for high-risk devices, plus 2,793 PMA supplements (changes to approved devices). The newest decision was on Sep 17, 2026.
1,327,834 reports in total: 10,113 deaths, 629,426 injuries and 684,796 malfunctions were reported. 83,565 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 | 1 | 0 | 84 |
| 2025 | 22 | 0 | 1 | 129 |
| 2024 | 37 | 0 | 1 | 98 |
| 2023 |
By product code, all years
All device makers and procedures · JNJ 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 JNJ 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.
| 37 |
| 0 |
| 0 |
| 97 |
| 2022 | 37 | 0 | 1 | 132 |
| 2021 | 30 | 0 | 1 | 150 |
| 2020 | 50 | 0 | 0 | 126 |
| 2019 | 40 | 0 | 0 | 156 |
| 2018 | 45 | 0 | 0 | 112 |
| 2017 | 31 | 0 | 1 | 149 |
| 2016 | 32 | 0 | 0 | 110 |
| 2015 | 36 | 0 | 1 | 103 |
| 2014 | 40 | 0 | 0 | 95 |
| 2013 | 47 | 0 | 1 | 104 |
| 2012 | 55 | 1 | 1 | 80 |
| 2011 | 34 | 0 | 0 | 28 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 44 | 28 | 60,960 | 2,099 |
| 2025 | 20 | 7 | 83,565 | 2,085 |
| 2024 | 52 | 4 | 98,025 | 2,235 |
| 2023 | 50 | 9 | 77,734 | 466 |
| 2022 | 25 | 0 | 71,842 | 323 |
| 2021 | 37 | 1 | 80,451 | 330 |
| 2020 | 44 | 0 | 72,408 | 182 |
| 2019 | 46 | 16 | 92,680 | 270 |
| 2018 | 59 | 1 | 71,315 | 191 |
| 2017 | 58 | 0 | 60,060 | 181 |
| 2016 | 82 | 0 | 63,089 | 168 |
| 2015 | 70 | 1 | 71,071 | 177 |
| 2014 | 51 | 2 | 61,224 | 218 |
| 2013 | 109 | 5 | 107,706 | 123 |
| 2012 | 119 | 4 | 60,870 | 190 |