On May 23, 2023, before the market opened, Integra filed a report with the SEC that stated, “Integra LifeSciences Holdings Corporation (the “Company”), after consultation with the U.S. Food and Drug Administration (the “FDA”), initiated a voluntary global recall of all products manufactured in its Boston, Massachusetts facility (the “Boston facility”) distributed between March 1, 2018 and May 22, 2023 (the “voluntary recall”). As a result, the Company concluded on May 22, 2023 that it expects it will incur an impairment charge related to the write-off of inventories, net, of approximately $22 million. The Company expects this charge will be recorded in the quarter ending June 30, 2023.” In addition, the report stated, “[t]he Company identified through an internal investigation process in its Boston facility deviations with endotoxin testing that may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, leading to a post-operative fever. Although there is no specific indication of any reported product complaints related to high endotoxin levels, the Company, in accordance with its commitment to patient safety and product quality, has decided to initiate the voluntary recall and extend the temporary halt of manufacturing at its Boston facility to implement additional detection and quality controls. The Company expects to resume manufacturing at its Boston facility following implementation of such controls. The voluntary recall includes the SurgiMend, PriMatrix, Revize™ and TissueMend™ products. The Company expects that the voluntary recall and manufacturing stoppage will have the greatest impact on the Tissue Technologies segment, including Private Label, and has revised guidance. For the second quarter, the Company expects reported revenues in the range of $372 million to $376 million and adjusted earnings per diluted share to be in the range of $0.55 to $0.59. While it is difficult to estimate at this time the impact of the voluntary recall for the full year, if the manufacturing stoppage continued through the remainder of 2023, the Company estimates full-year revenue and adjusted earnings per share guidance provided during the Company’s April earnings announcement would be negatively affected by approximately $60 million and $0.35, respectively. Products manufactured at the Boston facility represent approximately 5% of the Company’s consolidated revenues. The Company expects to provide updated details on its full-year guidance during its second quarter 2023 financial results conference call.”

On this news, Integra’s stock price fell $10.24 per share, or 20.19% to close at $40.48 per share on May 23, 2023.