Olympus is taking this recall action after having received 4 complaints between March 2024 and June 2024 from customers indicating the balloon was packaged with the incorrect Glo cath label applied to the balloon dilation catheter for the diameter sizes. The incorrect label states 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm. All other labeling is correct for the balloon, including the shelf box with front box label and circular star label and the balloon pouch. Recall start date: September 13, 2024
RecallTracker