Integra LifeSciences Corp. (NeuroSciences) — MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH AC
⚠️ Potential packaging failures, which could lead to a breach in the sterile barrier.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 16, 2026
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.).
What's affected?
- 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
- Lot code
- A24008
Additional details
(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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 55,276 units.
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