Integra MediHoney Gel wound dressing recalled for potential sterile packaging failure
Integra LifeSciences is recalling specific batches of MediHoney Gel wound dressing because the sterile packaging may fail, potentially allowing contamination. This affects models 31805 and 31815 distributed worldwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Integra LifeSciences recalls
What to do
- Check if you have MediHoney Gel Model 31805 or 31815 with the affected lot/serial numbers
- Stop using affected packages immediately
- Contact your healthcare provider or supplier for replacement or instructions
- Do not use the product even if the packaging appears intact
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 3 products — see all of them.
Details
- Units affected
- 49,367 units
- Illnesses reported
- None reported
- Manufactured in
- 1100 Campus Rd, Princeton, NJ, United States
- Classification
- Class II
- Recall number
- Z-1363-2026
In the FDA's words
- 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. Potential packaging failures, which could lead to a breach in the sterile barrier. 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: 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.). Affected quantity: 49,367 units
- Hazard
- Potential packaging failures, which could lead to a breach in the sterile barrier.
3 products in this recall
MediHoney and CVS wound dressings recalled for packaging failure
Integra LifeSciences is recalling three wound dressing products, including MediHoney Gel, MediHoney Calcium Alginate, and a CVS private label dressing. The packaging may fail, which could break the sterile barrier and let the dressing become contaminated. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides… (this page)Z-1363-2026 · 49,367 units
- MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTI…Z-1364-2026 · 55,276 units
- Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for mi…Z-1365-2026 · 2,906 units