DERMLITE DL4W Medical Device Recalled for Serial Number Labeling Discrepancy
DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error with no reported illnesses or injuries. Although classified as FDA Class II, the discrepancy is administrative in nature and does not describe a functional product defect or immediate patient safety hazard.
Plain-English summary
DermLite LLC is recalling DERMLITE DL4W medical devices (32 units, Lot #7654) due to incorrect package labeling. The devices were distributed worldwide, including in California, Arizona, Texas, Florida, Nebraska, Iowa, Missouri, Colorado, Saudi Arabia, Australia, and Spain.
The package labeling contains a different serial number than the serial number on the product itself. Affected serial numbers include DL4WGXXXX (1304-1353) and DL4WBXXXX (1504).
Users should verify that the serial number on their device package matches the serial number on the product. For additional information or guidance, contact DermLite LLC.
The recalled product
- Product
- DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
- Manufacturer
- DermLite LLC
- Category
- Medical Device
- Hazard
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 7654
- serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504)
- UDI-DI: (01) 0 8559970
Distribution
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