Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Brand Name: Valeda Light Delivery System Product Name: Light Based Recalled by LUMITHERA INC Due to U.S. customers were shipped devices that were configured...

Date: May 7, 2025
Company: LUMITHERA INC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LUMITHERA INC directly.

Affected Products

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

Quantity: 8

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LUMITHERA INC

LUMITHERA INC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report