FDAClass IIMay 10, 2023

Dermlite Dl4w recall: Labeling Error

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

Why was Dermlite Dl4w recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Recalling firm
DermLite LLC
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.
Recall date
May 10, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls