Z-1506-2023Class II

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

Name: Z-1506-2023 DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Creator: DermLite LLC
Published: 2023-03-20
License: https://open.fda.gov/license/

DermLite LLC / initiated 2023-03-20 / Open, Classified / root cause: labeling and UDI

FDA source

DermLite LLC began a recall of DERMLITE DL4W, REF: DL4W, Rx Only MD, CE on 2023-03-20. FDA classified it as Class II and gives the reason as "Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1506-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-20
Posted: 2023-05-04
Recalling firm: DermLite LLC
Product: DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Product code: KYT Light, Examination, Medical, Battery Powered
Reason for recall: Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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
Quantity in commerce: 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.
Product codes and lots: Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-05-04

Product code KYT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)