Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2046-2025 — 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

U.S. FDA — Device Enforcement · United States · 2025-05-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2046-2025
Date of alert: 2025-05-07
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: LUMITHERA INC
Product category: device
Product type: Devices

Reported risk: U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.