LUMITHERA INC: Device Recall
Recall #Z-2046-2025 · 05/07/2025
Class III: Low Risk
Recall Details
- Recall Number
- Z-2046-2025
- Classification
- Class III
- Product Type
- Device
- Recalling Firm
- LUMITHERA INC
- Status
- Ongoing
- Date Initiated
- 05/07/2025
- Location
- Poulsbo, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
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.
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.