DERMLITE DL4W — Class II medical device recall Z-1506-2023
Ongoing recall by DermLite LLC, reported 2023-05-10, distributed nationwide. Incorrect labeling; Package labeling contains a different serial number then the serial number on the product
| Recall number | Z-1506-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DermLite LLC, San Juan Capistrano, CA, United States |
| Recall initiated | 2023-03-20 |
| Classified | 2023-05-04 |
| Reported by FDA | 2023-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ES, SA |
| Quantity | 32 units |
| Reason classes | labeling |
| Lot numbers | 7654 |
| Serial numbers | DL4WBXXXX, DL4WGXXXX |
| Model numbers | DL4W |
Product
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Reason for recall
Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1506-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.