Integra LifeSciences Issues Recall Alert for Products
The FDA's Center for Devices and Radiological Health issued an Early Alert, saying it is aware that Integra LifeSciences (IART) has issued a letter to affected customers recommending all MediHoney Wound and Burn products and certain lots of CVS Wound Gel (CVS) be removed from where they are used or sold. "Do not use affected product," the FDA said. "Immediately identify and remove affected product from service." Integra LifeSciences identified packaging failures related to the MediHoney Wound and Burn products that could lead to a breach in the sterile barrier. Use of product with a breached sterile barrier could lead to patient infection. The inability to use the device due to packaging failures may delay care. If you have already used the products affected by this recall and standard operative care was followed, there is no additional patient follow-up required. Integra LifeSciences identified production and process control issues for certain CVS Wound Gel products. If the affected product is used, it may lead to infection. Users may not be able to use the device due to packaging failures. As of December 19, 2025, Integra LifeSciences has reported 11 serious injuries related to MediHoney Wound and Burn products, three serious injuries related to CVS Wound Gel products, and no deaths associated with this issue.
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Integra LifeSciences Faces Recall Due to Packaging Defects Linked to 11 Serious Injuries
- FDA Alert: The FDA has issued an early alert regarding potentially high-risk issues with Integra LifeSciences' MediHoney wound and burn care products, citing packaging and production failures that could lead to infection and compromise patient safety.
- Product Recall: Integra has notified customers to immediately cease the use of all MediHoney wound and burn products and specific lots of CVS Wound Gel, ensuring these products are removed from clinical settings to prevent further harm.
- Injury Reports: As of December 19, 2025, Integra reported 11 serious injuries linked to MediHoney products and three serious injuries associated with CVS Wound Gel, highlighting the severity of safety concerns despite no reported fatalities.
- Distributor Instructions: Integra instructed distributors to halt further distribution of affected products and manage customer communications directly, ensuring that impacted products are properly handled, reflecting the company's commitment to customer safety.
Integra LifeSciences CEO to Present at 44th Annual J.P. Morgan Healthcare Conference
- Conference Participation: Integra LifeSciences CEO Mojdeh Poul and CFO Lea Knight will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, showcasing the company's latest advancements in medical technology, which is expected to attract investor interest.
- Live Webcast: The presentation will be available via live webcast on Integra LifeSciences' investor relations website, enabling global investors to access real-time updates on the company, thereby enhancing transparency and investor confidence.
- Company Mission: Integra LifeSciences is committed to restoring patients' lives through innovative treatment pathways, demonstrating its leadership in surgical, neurologic, and regenerative care, which further solidifies its competitive position in the market.
- Brand Portfolio: The company offers a comprehensive portfolio of high-quality leadership brands aimed at meeting the evolving market demands through continuous innovation and high standards of medical solutions, driving long-term growth.
