Integra LifeSciences MEDIHONEY Calcium Alginate dressing recalled for sterile packaging failure
Integra LifeSciences has recalled certain lots of MEDIHONEY Calcium Alginate dressing due to potential packaging failures that could compromise the sterile barrier. If the sterile seal is broken, the wound dressing may become contaminated before use. This affects three model numbers distributed worldwide, including to healthcare facilities in the US and internationally.
From the FDA notice · Read the official notice ↗ · All Integra LifeSciences recalls
What to do
- Check the model number and lot number on your MEDIHONEY dressing package against the recall list
- Do not use the product if it matches an affected lot number
- Contact your supplier or Integra LifeSciences for instructions on replacement or disposal
- If you have already used an affected dressing, monitor the wound for signs of infection
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 3 products — see all of them.
Details
- Units affected
- 55,276 units
- Illnesses reported
- None reported
- Manufactured in
- 1100 Campus Rd, Princeton, NJ, United States
- Classification
- Class II
- Recall number
- Z-1364-2026
In the FDA's words
- Description
- MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds Potential packaging failures, which could lead to a breach in the sterile barrier. (1) Model Number: 31012; UDI-DI: 10381780486909; Lot numbers: A24008, A24057, B21123, B24075, C22159, C23177, C24148, D24190, E21365, E24254, E24255, G23393, H21523, H22452, H23443, I22512, I23464, J21693, L22706. (2) Model Number: 31022; UDI-DI: 10381780486916; Lot numbers: A23045, A23065, A25028, A25056, B23079, B25068, B25077, C21151, C21152, C21155, C21195, C22182, C22196, C23183, C23193, C25152, D23196, D23208, E21300, E22305, E22319, F21407, F21428, F21430, F22333, F24317, G23405, H21544, H22438, H23415, H23442, H23446, H24415, I21610, I21617, J22530 , J23551, J23560, J24622, K21723, K21739, K24625, K24646, L21838. (3) Model Number: 31045; UDI-DI: 10381780486923; Lot numbers: A21056, A22036, A22047, A24036, B21062, B21084, B21100, B21107, B21119, B25110, D21229, D21247, D22251, D22270, D22275, D23236, D23248, D24192, D24220, E21314, E21337, E21361, E22277, E23253, E23271, E24296, F21376, F22361, F22362, F22382, F23369, F23370, G21490, G21504, G22385, G23384, H21506, H21512, H21530, H23450, H23451, I22479, I22481, I22495, I23466, I23498, I24511, I24523, J21680, J21691, K21777, K21801, K21806, K22597, K22609, K22632, K22663, K24650, K24679, L21812, L21823, L22674, L22711, L23649. 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: 55,276 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…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… (this page)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