Recall Z-1363-2026
Integra LifeSciences Corp. (NeuroSciences) · initiated January 16, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Potential packaging failures, which could lead to a breach in the sterile barrier.
FDA-determined cause: Under Investigation by firm
Action taken
Integra began notifying consignees on about 01/16/2026 via URGENT: VOLUNTARY MEDICAL DEVICE RECALL letter sent through FedEx and email. Consignees were instructed to immediately cease use of affected units and arrange for their return. Users were instructed to follow-up with their medical provider if the product has been used and they experienced any signs of wound infection. Consignees and distributors were instructed to forward the notification to those who utilize the product for awareness, and to customers, if further distributed. Additionally, consignees and distributors were requested to complete and return the provided Acknowledgement Form.
Details
- Recall number
- Z-1363-2026
- Initiated
- January 16, 2026
- Posted by FDA
- February 13, 2026
- Product code
- FRO – Dressing, Wound, Drug
- Quantity
- 49,367 units
- 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…
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1364-2026 Class II | MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2)…Potential packaging failures, which could lead to a breach in the sterile barrier. | 01/16/2026Open, Classified |
| Z-1365-2026 Class II | Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment…Potential packaging failures, which could lead to a breach in the sterile barrier. | 01/16/2026Open, Classified |