BEUDAMED
    FDA Enforcement Class I Ongoing

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

    Recall: Z-2254-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2254-2026
    Event ID
    98842
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    April 27, 2026
    Classification Date
    May 29, 2026
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

    Reason

    This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

    Code Info

    Catalog Number: 405658. UDI Number: (01)00382904056582(17)261001(10)B01V217D. Lot Number (Expiration Date): B01V217D (2026-10-01).

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

    Quantity

    150 units