WINGDERM ELECTRO-OPTICS LTD.: Medical Device Recall in 2024 - (Recall #: Z-0555-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 23, 2024

Date Posted: December 11, 2024

Recall Number: Z-0555-2025

Event ID: 95831

Reason for Recall:

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)

Status: Ongoing

Product Quantity:

Code Information:

F7201110001 F1210910001 F1210910002 F7211210001 F7226110002 F7227110001

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

FDA Mandated