---
title: "Brand Name: Valeda Light Delivery System Product Name: Light Based Device for... — FDA record Z-2046-2025 | Is It on Recall"
description: "U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet."
url: https://isitonrecall.com/recall/fda-device-z-2046-2025-brand-name-valeda-light-delivery-system-product-name-light-based-device-for-dry-age-related-macular/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Pr... — FDA record Z-2046-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **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.
- **Classification**: Class III
- **Recalling firm**: LUMITHERA INC
- **Quantity**: 8
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2046-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2046-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Hawaii](https://isitonrecall.com/state/hawaii/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Maine](https://isitonrecall.com/state/maine/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Montana](https://isitonrecall.com/state/montana/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [North Dakota](https://isitonrecall.com/state/north-dakota/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New Mexico](https://isitonrecall.com/state/new-mexico/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Vermont](https://isitonrecall.com/state/vermont/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Jul 9, 2025
- **Recall initiation date**: May 7, 2025
- **Center classification date**: Jun 30, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2046-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [LUMITHERA INC records](https://isitonrecall.com/brand/lumithera-inc/)