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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

MediHoney Wound & Burn Dressing Gel Recalled for Packaging Seal Issues

Agency Publication Date: February 12, 2025
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Summary

Integra LifeSciences Corp. is recalling approximately 12,166 units of MediHoney Wound & Burn Dressing Gel (Model 31815) because the induction seal on the tube packaging may not be completely sealed. This gel is used as a medical-grade honey dressing to maintain a moist environment for wound and burn healing. No injuries have been reported to date. The recall affects specific batches sold nationwide and internationally.

Risk

A compromised or incomplete seal on the dressing tube can lead to product leakage or contamination. Using a contaminated dressing on wounds or burns could lead to infection or delayed healing.

What You Should Do

  1. This recall affects MediHoney Wound & Burn Dressing Gel, Model/Catalog Number 31815, with UDI 10381780486886 and lot numbers 2328, 2332, and 2333.
  2. Stop using the product immediately if it belongs to one of the affected lot numbers.
  3. Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Integra LifeSciences Corp. for further instructions.
  4. Contact your healthcare provider if you have used this product and have concerns about wound healing or signs of infection.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
🗑️Option 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: MediHoney Wound & Burn Dressing Gel
Variants: 80% medical grade honey
Model / REF:
31815
Lot Numbers:
2328
2332
2333
UDI:
10381780486886

MediHoney Gel with Active Leptospermum Honey and gelling agents.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96109
Status: Active
Manufacturer: Integra LifeSciences Corp.
Sold By: Nationwide distribution; Malaysia
Manufactured In: United States
Units Affected: 12,166 units
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.