FDA (Devices) recall action 95831
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
All model WLA-01 systems sold to US customers are found to have 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)
The agency’s own wording, quoted from the enforcement report.
WINGDERM ELECTRO-OPTICS LTD. is recalling all WLA-01 diode laser hair removal systems sold to US customers due to labeling non-compliances.
Non-ablative Fractional Laser Systems Model WFB-01 are recalled due to a software bug affecting 6 units sold to US customers before August 23, 2022, and labeling non-compliances affecting 22 units sold to US customers.