Boston Scientific (NYSE: BSX) disclosed in an SEC filing:

On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered that all manufacturers of surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse stop selling and distributing their products in the United States immediately, stemming from the FDA’s 2016 reclassification of these devices to class III (high risk) devices. The FDA’s order applies to two Boston Scientific product lines, Uphold™ LITE Vaginal Support System and Xenform™ Soft Tissue Repair Matrix. As a result, Boston Scientific anticipates an approximate $25 million negative impact globally to 2019 full year revenue. Boston Scientific continues to assess any potential additional impact to the business and will provide a further update on its conference call discussing financial results and business highlights for the first quarter ended March 31, 2019 on Wednesday, April 24, 2019 at 8:00 a.m. EDT.