Recall archive / FDA device enforcement
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: Med... — FDA record Z-2506-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Packaging failures were identified which could lead to a breach in the sterile barrier.
- Classification
- Class II
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 141620 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2506-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 10, 2025
- Recall initiation date
- Aug 5, 2025
- Center classification date
- Sep 3, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.