DermLite DL4W (DermLite) – incorrect serial number (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Brand
DermLite LLC
Lot Codes / Batch Numbers
Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504), UDI-DI: (01) 0 8559970
Products Sold
Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
DermLite LLC is recalling DERMLITE DL4W, REF: DL4W, Rx Only MD, CE due to Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
Recommended Action
Per FDA guidance
On March 20, Dermlite LLC sent customers an email informing them of the issue. On March 29, 2023, Dermlite LLC, issued an "Urgent Medical Device Recall" via phone call. In addition to informing consignees about the recall, Dermlite asked consignees to take the following actions: 1. Inspect your inventory and segregate the affected products from being used/sold. 2. Dermlite will issue a corrected box label(s) and overnight it to your firm. 3. For distributors: please trace where the remaining DL4W s were sold. If the products have left your facility to an end user, please notify the customer of this recall, provide corrected box label(s) to the customer and have them confirm when the boxes have been properly relabeled. 4.Please confirm that you acknowledge receipt of this information and have understanding of the recall
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026