Valeda light therapy devices shipped with European Union electrical configuration
Eight Valeda Light Delivery Systems are being recalled because US customers were shipped devices configured for the European Union that could not be plugged into the outlet.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall over a regional electrical configuration that prevents the device from being connected at all, with no route to patient harm described.
Plain-English summary
The Valeda Light Delivery System, a light based device for dry age related macular degeneration, is being recalled. The action covers 8 units, identified by the serial numbers and UDI-DI codes listed in the recall notice.
The stated reason is that US customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet. The FDA classified the action as Class III, its least serious classification.
Distribution was nationwide in the United States, in Arizona, California, Florida, Illinois, North Dakota, Tennessee and Texas. The systems are supplied to eye care facilities rather than sold to consumers.
Facilities should identify affected units using the serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- 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
- Manufacturer
- LUMITHERA INC
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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 20170
Distribution
Related recalls
Same hazard · wrong configuration
See all →- ModerateSurgical guard attachments recalled after long and standard labels were swapped
FDA (Devices) · 2025-10-08
- ModerateSurgical instrument attachments recalled after standard and long versions were mislabeled
FDA (Devices) · 2025-10-08
Other medical device recalls
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
Similar recalls
- ModerateQuasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System
FDA (Devices) · 2018-09-12
- HighOptimedica Catalys Precision Laser System Recalled for Transformer Heating Risk
FDA (Devices) · 2014-01-15
- HighLumenis Vision One Laser System Recalled for Unintended Laser Exposure
FDA (Devices) · 2013-09-18
- HighMedical Device Recall: Illuminated Laser Probe with Incorrect Expiration Date
FDA (Devices) · 2021-07-28
- HighMaquet Operating Room Light Systems Recalled Due to Fall Risk
FDA (Devices) · 2024-01-24
- HighRobotic-Assisted Medical Device Recalled Due to Software Defect
FDA (Devices) · 2022-05-11