FDA Device recall Z-1506-2023
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of DERMLITE DL4W, REF: DL4W, Rx Only MD, CE by Dermlite, citing incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1506-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-20 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dermlite |
| Distribution | US |
Product
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Reason
Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
Identifiers
| code_info | Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1506-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.