There are potential for pinholes in the applicator pouch film which creates a sterility concern. Manufacturer reported that there have been 4 complaints reported worldwide with the potential to be related to this sterility concern as of 08/05/2024, none of which alleged serious injury or deaths. Additionally, these products were found to be unlicensed for sale in Canada and were distributed without a license. Recall start date: September 16, 2024
RecallTracker