FDA Medical Device Recalls (openFDA)
DermLite LLC: DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
- Recall number
- Z-1506-2023
- Recalling firm
- DermLite LLC
- Product
- DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
- Status
- Open, Classified
- Initiated
- 2023-03-20
- Posted
- 2023-05-04
- Terminated
- not on file
- Reason
- Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
- 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
- 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.
- Lot, serial or model codes
- Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYT
- Firm FEI
- 3003452144
- Firm city
- San Juan Capistrano
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28