Medical device recalls Moderate risk

Integra LifeSciences Corp. (NeuroSciences) recalls MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with…

Recall date
January 16, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1363-2026
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp. (NeuroSciences)
Sold / distributed
Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republ…

Why it was recalled

Potential packaging failures, which could lead to a breach in the sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.

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