Integra LifeSciences Corp. (NeuroSciences) recalls Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 an…

Packaging failures were identified which could lead to a breach in the sterile barrier.

Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.

On August 5, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions for Customers: If you have units of the impacted product remove them immediately from service and quarantine them. Forward this notice to those who utilize the product so they are aware of this recall and can identify any affected product that may remain in clinical areas. Complete the entirety of the Acknowledgement Form and send via email to FCA4@integralife.com or FAX to 1-609-750-4220. Keep a copy of the form for your records. Actions for Distributors: If you have products listed in Table 1, remove the product from further distribution. Complete the entirety of the Acknowledgement Form and send via email to FCA4@integralife.com or FAX to 1-609-750-4220. Keep a copy of the form for your records. Check your customer traceability records and notify them if they have any shipments of above catalog and lot numbers. Modify the acknowledgement form to create one from you to your customers. Collect completed response forms and affected product from your customers and indicate total quantities and lots in distributor reply form. For questions regarding these instructions, please contact Customer Service: Monday - Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873 email: custsvcnj@integralife.com Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Integra is dedicated to patient safety and manufacturing excellence. We continue to make numerous quality improvements and investments in our facilities around the world. In addition, we are improving our processes in accordance with applicable regulations. We sincerely apologize for any inconvenience this voluntary recall may cause and thank you for your cooperation in this effort.

• FDA enforcement recordOfficial FDA database entry for Z-2506-2025
• FDA 510(k) clearance · K080315The device's official FDA premarket clearance record
• FDA device classification · FROOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.