DermLite LLC: Medical Device Recall in 2023 - (Recall #: Z-1506-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

Product Classification:

Class II

Date Initiated: March 20, 2023

Date Posted: May 10, 2023

Recall Number: Z-1506-2023

Event ID: 91987

Reason for Recall:

Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

Status: Ongoing

Product Quantity: 32 units

Code Information:

Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated