Integra LifeSciences Recalls MediHoney Gel Due to Potential Sterile Barrier Breach
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Integra LifeSciences Corp. has voluntarily recalled over 49,000 units of MediHoney Gel dressings because packaging failures may compromise the product's sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on March 3, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Integra LifeSciences Corp. (NeuroSciences) has initiated a voluntary recall of its MediHoney Gel with Active Leptospermum Honey. The recall was prompted by the discovery of potential packaging failures. These defects could lead to a breach in the sterile barrier of the product, which is intended to provide a moist environment for wound healing.
Which Products Are Affected
The recall involves 49,367 units of MediHoney Gel distributed worldwide. The affected products include:
- Product Name: MediHoney Gel with Active Leptospermum Honey
- Model/Catalog Number 31805: UDI-DI 10381780486978; Serial numbers 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515.
- Model/Catalog Number 31815: UDI-DI 10381780486886; Lot numbers 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.
In the United States, distribution was confirmed in Texas, Michigan, Florida, Indiana, Missouri, California, Virginia, New Jersey, Pennsylvania, South Carolina, Tennessee, Rhode Island, and New York. International distribution includes Australia, Canada, the United Kingdom, and several other countries across Europe, the Middle East, and Asia.
What You Should Do
Integra LifeSciences is notifying customers through multiple channels, including email, fax, letter, press release, telephone, and direct visits. Consumers and healthcare providers should immediately check their inventory for the model and lot numbers listed above. If you possess affected products, follow the instructions provided in the firm's notification regarding the return or disposal of the units.
Why This Matters
A breach in the sterile barrier of a medical dressing can introduce contaminants to a wound site. This poses a significant risk of infection for patients using the gel to treat light to moderately exuding wounds.
Source
This information is based on official recall data from the FDA. Recall Number: Z-1363-2026.
Original source: FDA Official Notice ↗
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