Integra LifeSciences Recalls MediHoney Gel for Packaging Issues
Integra LifeSciences Corp. recalled 49,367 units of MediHoney Gel on January 16, 2026. The recall follows potential packaging failures that may compromise the sterile barrier. Affected products include model numbers 31805 and 31815, distributed worldwide.
Quick Facts at a Glance
Recall Date
January 16, 2026
Hazard Level
HIGH
Brand
Integra LifeSciences Corp.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
Potential packaging failures, which could lead to a breach in the sterile barrier.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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About This Product
MediHoney Gel is a wound dressing used to create a moist environment conducive to healing. It is indicated for light to moderately exuding wounds and provides a natural approach to wound care.
Why This Is Dangerous
The packaging failures could allow bacteria to enter the product, compromising its sterility and potentially leading to infections in patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the affected products may face health risks and should take immediate action to stop use and follow recall procedures.
Practical Guidance
How to identify if yours is affected
Check if your product has model numbers 31805 or 31815.
Look for the UDI-DI codes on the packaging: 10381780486978 for model 31805 and 10381780486886 for model 31815.
Verify the lot numbers against the recalled lot numbers: 2405-2422, 2432-2433, 2513-2515.
Where to find product info
You can find the model and lot numbers printed on the product packaging or on the box it came in.
What timeline to expect
Expect a refund or replacement within 4-6 weeks after returning the product.
If the manufacturer is unresponsive
Document all correspondence with the company.
Follow up with a phone call if you do not receive a response within a week.
Consider filing a complaint with the FDA if the company remains unresponsive.
How to prevent similar issues
When purchasing medical devices, check for proper seals and packaging integrity.
Always review recall notices for medical products.
Choose products from reputable brands that have safety certifications.
Documentation advice
Keep a record of your purchase, any correspondence with the manufacturer, and take photos of the product and packaging.
Product Details
The recall involves MediHoney Gel with Active Leptospermum Honey. The affected model numbers are 31805 and 31815. The product was sold worldwide, including across various U.S. states and several countries.
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