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Recall Observatory FDA recall evidence

Device product

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.

Z-1363-2026

January 16, 2026

Class II

Product summary

Firm
Integra LifeSciences Corp. (NeuroSciences)
Event
Event 98175
Status
Ongoing
Classification
Class II
Quantity
49,367 units
Official record key
device-enforcement:Z-1363-2026

Official wording

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

Code information: 1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.

Distribution pattern: 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.).

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in the sterile barrier