FDAFDA · Food and drugs·Recall number Z-0555-2025
Non-ablative Fractional Laser Systems, Model: WFB-01
Published December 11, 2024 · Recall initiated: August 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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)
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- WINGDERM ELECTRO-OPTICS LTD.
- Distributor
- Worldwide Distribution
- Lot
- F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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