LUMITHERA INC: Medical Device Recall in 2025 - (Recall #: Z-2046-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class III

Date Initiated: May 7, 2025

Date Posted: July 9, 2025

Recall Number: Z-2046-2025

Event ID: 96892

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.

Status: Ongoing

Product Quantity: 8

Code Information:

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 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R; Serial Number 20170

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.

Voluntary or Mandated:

Voluntary: Firm initiated