Integra LifeSciences Recalls MEDIHONEY Calcium Alginate Dressings Due to Potential Sterility Breach

What Happened

Integra LifeSciences Corp. (NeuroSciences) has initiated a voluntary recall of MEDIHONEY Calcium Alginate dressings. The recall was prompted by potential packaging failures that could lead to a breach in the product’s sterile barrier. This issue was identified as a Class II recall by the FDA.

Which Products Are Affected

The recall affects 55,276 units of MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. These dressings are indicated for the management of moderately to heavily exuding wounds. The following models and lot numbers are included:

• Model Number 31012 (UDI-DI: 10381780486909): Lots A24008, A24057, B21123, B24075, C22159, C23177, C24148, D24190, E21365, E24254, E24255, G23393, H21523, H22452, H23443, I22512, I23464, J21693, L22706.
• Model Number 31022 (UDI-DI: 10381780486916): Lots 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.
• Model Number 31045 (UDI-DI: 10381780486923): Lots 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 was worldwide, including the U.S. states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, and NY.

What You Should Do

Integra LifeSciences has notified customers through email, fax, letter, press release, telephone, and direct visits. Healthcare providers and consumers should immediately check their inventory for the affected lot numbers. If you possess any of the recalled products, follow the instructions provided in the firm’s notification for returns or disposal.

Why This Matters

A breach in the sterile barrier of a medical dressing intended for wound care can lead to contamination, potentially increasing the risk of infection for patients.

Source

FDA (Recall Number: Z-1364-2026)