Z-2506-2025 Class II Ongoing
FDA device recall Z-2506-2025 was initiated by Integra LifeSciences Corp. (NeuroSciences) on August 5, 2025 and is designated Class II. Reason for recall: Packaging failures were identified which could lead to a breach in the sterile barrier. The recall status is ongoing. Affected quantity: 141620 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- August 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141620 units
Product Description
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.
Reason for Recall
Packaging failures were identified which could lead to a breach in the sterile barrier.
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.
Code Information
Model/Catalog Number: (1) 31515 and (2) 31535; UDI - (1) 10381780486824, (2) 10381780486831; lot#s: (1) 2123, 2211, 2124, 2212, 2127, 2213, 2128, 2222, 2129, 2223, 2132, 2232, 2133, 2233, 2137, 2243, 2136, 2244, 2143, 2309, 2150, 2307, 2210, (2) 2108, 2242, 2116, 2306, 2123, 2313, 2124, 2315, 2138, 2333, 2139, 2339, 2201, 2404, 2209, 2423, 2213;