Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Des...
FDA Recall #Z-2505-2025 — Class II — August 5, 2025
Product Description
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 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.
Reason for Recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15441 units
Distribution
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.
Code Information
Model/Catalog Number: 31505; UDI: 10381780486930; Lot #s: 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2232, 2428, 2241, 2434, 2301, 2435, 2312, 2505, 2313, 2508, 2314, 2509, 2328;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated