Beijing, China
WINGDERM ELECTRO-OPTICS LTD. recalls
1 recall recorded since 2018, most recently on 23 August 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 August 2024
- Reason
- 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)
- Distribution
- Worldwide Distribution
- Initiated
- FDA Mandated
- Recall numbers
- Z-0555-2025, Z-0556-2025
- Non-ablative Fractional Laser Systems, Model: WFB-01
- Diode Laser Hair Removal model: WLA-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.