CLASS III ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
Valeda Light Delivery System Light Based Device recalled by Lumithera
Lumithera is recalling Valeda Light Delivery System Light Based Device for Dry Age Related Macular Degeneration, distributed nationwide in the US. The recall was initiated on 7 May 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2046-2025
- FDA event ID
- 96892
- Recalling firm
- Lumithera, Poulsbo, WA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 7 May 2025
- FDA classified
- 30 Jun 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 May 2025 | Recall initiated by company | |
| 30 Jun 2025 | Classified by FDA | +54 days |
| 9 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
Nationwide ArizonaCaliforniaFloridaIllinoisNorth DakotaTennesseeTexas
Questions about this recall
Is Valeda Light Delivery System Light Based Device for Dry Age Related Macular Degeneration recalled?
Yes. Lumithera recalled Valeda Light Delivery System Light Based Device for Dry Age Related Macular Degeneration on 7 May 2025. The recall is Class III and its status is Ongoing. Recall number Z-2046-2025.
Why was it recalled?
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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