FDA DevicesClass II
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, ...
Published: February 25, 2026Recall ID: Z-1363-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential packaging failures, which could lead to a breach in the sterile barrier.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Event id | 98175 |
| Address 1 | 1100 Campus Rd |
| Code info | 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. |
| Postal code | 08540-6650 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 49,367 units |
| Reason for recall | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260116 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260213 |
Overview
- Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.).