The Recall Desk
HighFDA (Devices)·Z-2046-2025·Announced 2025-07-09

[pending] Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macul

Pending LLM rewrite. Source: FDA_DEVICE Z-2046-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

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
Manufacturer
LUMITHERA INC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T
  • Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W
  • Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X
  • Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y
  • Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z
  • Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W
  • Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y
  • Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z
  • Serial Number 20170

Distribution

Distributed nationwide across the United States.

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