BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1364-2026 · Initiated January 16, 2026

    Recall

    Recall Number
    Z-1364-2026
    Event Number
    98175
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    FEI Number
    3003418325
    Product Code
    FRO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 16, 2026
    Posted
    February 13, 2026
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    Description

    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

    Reason

    Potential packaging failures, which could lead to a breach in the sterile barrier.

    Action

    Integra began notifying consignees on about 01/16/2026 via URGENT: VOLUNTARY MEDICAL DEVICE RECALL letter sent through FedEx and email. Consignees were instructed to immediately cease use of affected units and arrange for their return. Users were instructed to follow-up with their medical provider if the product has been used and they experienced any signs of wound infection. Consignees and distributors were instructed to forward the notification to those who utilize the product for awareness, and to customers, if further distributed. Additionally, consignees and distributors were requested to complete and return the provided Acknowledgement Form.

    Distribution

    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.).

    Quantity

    55,276 units