Class II

Medical Device Recall: 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 heal

Integra LifeSciences Corp. (NeuroSciences) · January 16, 2026

Reason for Recall

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

Product Description

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.

Distribution

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 Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).

States Affected

NATIONWIDE

Quantity Affected

49,367 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1363-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.