Poulsbo, WA, United States
LUMITHERA INC recalls
1 recall recorded since 2018, most recently on 7 May 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 7 May 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2046-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.