Wingderm recalls 28 units of WFB-01 non-ablative fractional laser systems sold to US customers before August 2022 due to software bugs and labeling non-compliances.
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)
Wingderm is recalling 28 units of their WFB-01 non-ablative fractional laser systems sold to US customers before August 23, 2022. The recall is due to software bugs and labeling non-compliances that could affect safety and regulatory compliance.
The software bug in the WFB-01 models could lead to improper operation, while labeling non-compliances might result in incorrect usage instructions. These issues are not expected to cause serious injury but require attention for regulatory compliance.
US customers who purchased WFB-01 laser systems before August 23, 2022 are affected. Those with the specific serial numbers listed are most at risk.
Check for the model WFB-01 with serial numbers F7201110001, F1210910001, F1210910002, F7211210001, F7226110002, or F7227110001. The recall applies to units sold to US customers before August 23, 2022.
Verify if your device has one of the listed serial numbers: F7201110001, F1210910001, F1210910002, F7211210001, F7226110002, or F7227110001.
28 units: 6 with software bugs and 22 with labeling non-compliances.
The recall does not specify a remedy, so contact Wingderm directly for guidance.
The recall states there is a software bug but does not indicate it causes serious injury or death in normal use.
We’ve drafted a message you can send Wingderm to request your refund or repair — edit it as you like.
Subject: Recall Z-0555-2025 — Wingderm Wingderm Hello, I own a Wingderm that is covered by recall Z-0555-2025 from Wingderm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
