Stock: RMD. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
137
De Novo: 0
PMA approvals
0
0 supplements
Recalled products
14
10 class I
Adverse event reports
18K
216 deaths reported
ResMed has 14 recalled medical device products in 8 recall actions in the records, 10 of them class I (the most serious kind). The newest recall started on Jun 25, 2026. In 2023 it had 8 recalled products.
137 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Aug 27, 2026.
18,415 reports in total: 216 deaths, 623 injuries and 17,495 malfunctions were reported. 968 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 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · RMD 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 RMD 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 |
| 0 |
| 2021 | 1 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 |
| 2018 | 3 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 |
| 2016 | 8 | 0 | 0 | 0 |
| 2015 | 4 | 0 | 0 | 0 |
| 2014 | 7 | 0 | 0 | 0 |
| 2013 | 9 | 0 | 0 | 0 |
| 2012 | 9 | 0 | 0 | 0 |
| 2011 | 4 | 0 | 0 | 0 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 1 | 1 | 642 | 12 |
| 2025 | 0 | 0 | 968 | 14 |
| 2024 | 0 | 0 | 1,000 | 10 |
| 2023 | 8 | 8 | 1,468 | 16 |
| 2022 | 0 | 0 | 1,790 | 17 |
| 2021 | 0 | 0 | 2,599 | 24 |
| 2020 | 0 | 0 | 2,617 | 18 |
| 2019 | 1 | 1 | 785 | 12 |
| 2018 | 0 | 0 | 1,809 | 15 |
| 2017 | 0 | 0 | 1,849 | 9 |
| 2016 | 2 | 0 | 1,403 | 10 |
| 2015 | 1 | 0 | 1,034 | 19 |
| 2014 | 0 | 0 | 139 | 5 |
| 2013 | 0 | 0 | 44 | 3 |
| 2012 | 0 | 0 | 66 | 9 |