Class II — DermLite LLC
| Recalling firm | DermLite LLC |
|---|---|
| Registered facility | DermLite LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. |
| Product | DERMLITE DL4W, REF: DL4W, Rx Only MD, CE |
| Quantity | 32 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain. |
| Initiated | 2023-03-20 |
| Classified | 2023-05-04 |
| Recall number | Z-1506-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DermLite LLC (Z-1506-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91987/
Alerts for DermLite LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.