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FDAAugust 23, 2024device

Non-ablative Fractional Laser Systems, Model: WFB-01

Official recall recorded by the U.S. Food & Drug Administration.

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 enforcement status: Ongoing

Brands named

wingderm electro opticswingdermwingderm electro

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Non-ablative Fractional Laser Systems, Model: WFB-01 — Recall Details · AllClear