WINGDERM ELECTRO-OPTICS LTD. 2024-12-11 Health serious FDA
Health · FDA · Recall #FDA-Z-0555-2025
Non-ablative Fractional Laser Systems, Model: WFB-01 Recall
Issued December 11, 2024 · WINGDERM ELECTRO-OPTICS LTD.
In December 2024, WINGDERM ELECTRO-OPTICS LTD. recalled the Non-ablative Fractional Laser Systems, Model: WFB-01, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Non-ablative Fractional Laser Systems, Model: WFB-01 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact WINGDERM ELECTRO-OPTICS LTD. to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- WINGDERM ELECTRO-OPTICS LTD.
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- Worldwide Distribution
- Recall number
- FDA-Z-0555-2025
- Made in
- China
- Issuing agency
- FDA
In context
- WINGDERM ELECTRO-OPTICS LTD. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.