FDA Medical devices recall ·
MediHoney ¿ Product Name: MediHoney ¿ Tube Model recall
- Recall number
- Z-2506-2025
- Date
- (initiated August 5, 2025)
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 141620 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Packaging failures were identified which could lead to a breach in the sterile barrier.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
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: Alaska Alabama Arkansas Arizona California Colorado 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2506-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.