Integra LifeSciences Recalls MediHoney & CVS Wound Products Over Sterility Breach

Integra LifeSciences Holdings Corporation has initiated a recall of all MediHoney Wound and Burn Dressing products and specific lots of CVS Wound Gel. The recall, classified by the FDA as a Class I recall—the most serious type—is due to a potential breach of the product's sterile barrier. A breach in the sterile barrier compromises the product's sterility, posing a significant risk of infection when applied to open wounds or burns. The affected MediHoney products include various dressing sizes and formats, while the CVS Wound Gel recall is limited to specific lot numbers. The company is instructing customers and healthcare facilities to immediately stop using the affected products, quarantine any remaining inventory, and contact Integra for return instructions. The recall is being conducted as a correction and removal, not a product return to the consumer level. Integra has notified its distributors and is working to address the issue. Healthcare professionals and patients are advised to monitor for signs of infection if the products have already been used and to report any adverse events to the FDA's MedWatch program.