Reported Jul 9, 2025 · Ongoing

Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration…

Lumithera Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LUMITHERA INC · 19578 10th Ave Ne Ste 200 · Poulsbo, WA · 98370-7332

Is this the product you have?

  • Brand NameValeda
  • Light Delivery System Product NameLight Based Device for Dry Age Related Macular
  • Degeneration Product DescriptionLight Based Device for Dry Age
  • Related Macular Degeneration ComponentNo
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T
2Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W
3Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X
4Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y
5Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z
6Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W
7Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y
8Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z
9Serial Number 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R
10Serial Number 20170
Amount recalled
8

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.