Brand Name: Valeda Light Delivery System Product Name: Light Based… — Class III medical device recall Z-2046-2025
Ongoing recall by LUMITHERA INC, reported 2025-07-09, distributed nationwide. U.S. customers were shipped devices that were configured for the European Union and were unable to plug the de
| Recall number | Z-2046-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUMITHERA INC, Poulsbo, WA, United States |
| Recall initiated | 2025-05-07 |
| Classified | 2025-06-30 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Serial numbers | 20166, 20167, 20168, 20169, 20170, 20172, 20175, 20177, 20178 |
Product
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 Component: No
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2046-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.