Drug recall
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular…
FDA recall event 96892 · Class III · LUMITHERA INC
Key facts
| Event ID | 96892 |
|---|---|
| Recall numbers | Z-2046-2025 |
| Recalling firm | LUMITHERA INC |
| Product type | Devices |
| Products | Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet. |
| Initiation date | May 7, 2025 |
| Report date | Jul 9, 2025 |
| City | Poulsbo |
| State | WA |
| Country | United States |
| FEI number | 3016232028 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: