FDA Device recall Z-0555-2025
Non-ablative Fractional Laser Systems, Model: WFB-01
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Non-ablative Fractional Laser Systems, Model: WFB-01 by Wingderm Electro Optics, citing 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-compliance….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0555-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-23 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Wingderm Electro Optics |
| Distribution | n/a |
Product
Non-ablative Fractional Laser Systems, Model: WFB-01
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)
Identifiers
| code_info | F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0555-2025%22
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