BEUDAMED
    FDA Recall Open, Classified

    Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

    Recall: Z-2231-2026 · Initiated April 10, 2026

    Recall

    Recall Number
    Z-2231-2026
    Event Number
    98837
    FEI Number
    1417592
    Product Code
    CAI
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    April 10, 2026
    Posted
    May 28, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

    Reason

    Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

    Action

    Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following: - Identify and quarantine the affected item and lot numbers (kit). - Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided. - Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component. - Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.

    Quantity

    1100 kits