Non-ablative Fractional Laser Systems — Class II medical device recall Z-0555-2025
Ongoing recall by WINGDERM ELECTRO-OPTICS LTD., reported 2024-12-11. Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB
| Recall number | Z-0555-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | WINGDERM ELECTRO-OPTICS LTD., Beijing, China |
| Recall initiated | 2024-08-23 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Reason classes | labeling, software |
| Model numbers | WFB-01 |
Product
Non-ablative Fractional Laser Systems, Model: WFB-01
Reason for recall
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
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-0555-2025. 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.