Stock: BLCO. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
138
De Novo: 0
PMA approvals
33
877 supplements
Recalled products
141
2 class I
Adverse event reports
25K
4 deaths reported
Bausch + Lomb has 141 recalled medical device products in 41 recall actions in the records, 2 of them class I (the most serious kind). The newest recall started on Jun 6, 2025. In 2020 it had 2 recalled products.
138 510(k) clearances, 0 De Novo grants and 33 original PMA approvals for high-risk devices, plus 877 PMA supplements (changes to approved devices). The newest decision was on Sep 3, 2026.
25,012 reports in total: 4 deaths, 12,177 injuries and 12,585 malfunctions were reported. 386 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 | 0 | 0 | 0 | 6 |
| 2025 | 0 | 0 | 0 | 19 |
| 2024 | 1 | 0 | 1 | 13 |
| 2023 |
By product code, all years
All device makers and procedures · BLCO 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 BLCO 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 |
| 4 |
| 2022 | 1 | 0 | 0 | 13 |
| 2021 | 3 | 0 | 0 | 12 |
| 2020 | 2 | 0 | 0 | 12 |
| 2019 | 2 | 0 | 0 | 9 |
| 2018 | 2 | 0 | 0 | 12 |
| 2017 | 7 | 0 | 0 | 9 |
| 2016 | 2 | 0 | 0 | 16 |
| 2015 | 2 | 0 | 0 | 15 |
| 2014 | 4 | 0 | 0 | 23 |
| 2013 | 6 | 0 | 0 | 13 |
| 2012 | 5 | 0 | 0 | 17 |
| 2011 | 1 | 0 | 0 | 3 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 0 | 0 | 215 | - |
| 2025 | 3 | 2 | 386 | - |
| 2024 | 0 | 0 | 366 | - |
| 2023 | 0 | 0 | 294 | - |
| 2022 | 0 | 0 | 363 | - |
| 2021 | 0 | 0 | 318 | - |
| 2020 | 2 | 0 | 389 | - |
| 2019 | 0 | 0 | 493 | - |
| 2018 | 14 | 0 | 463 | 3 |
| 2017 | 45 | 0 | 3,198 | - |
| 2016 | 4 | 0 | 1,363 | - |
| 2015 | 3 | 0 | 3,177 | 1 |
| 2014 | 5 | 0 | 878 | - |
| 2013 | 1 | 0 | 862 | - |
| 2012 | 1 | 0 | 720 | - |