# FDA recall Z-2046-2025

> **LUMITHERA INC** · Class III · device recall initiated 2025-05-07.

## 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.

## Distribution

US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.

## Key facts

- **Recall number:** Z-2046-2025
- **Recalling firm:** LUMITHERA INC
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Poulsbo, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2025

## Citation

> AI Analytics. FDA recall Z-2046-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2046-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*