—#215518

Product

Brand Name: MediHoney Product Name: MediHoney HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing.

FDA product code: FRO — Dressing, Wound, Drug
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K110546
Affected lot / code info: Model/Catalog Number: 31738; UDI- 10381780486961; Lot # 53824;

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp. (NeuroSciences)
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

Timeline

Recall initiated: 2025-08-05
Posted by FDA: 2025-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215518. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.