BEUDAMED
    FDA Recall Open, Classified

    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B

    Recall: Z-2586-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-2586-2026
    Event Number
    99062
    FEI Number
    1417592
    Product Code
    OJG
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    February 27, 2026
    Posted
    June 25, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B

    Reason

    Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

    Action

    This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.

    Distribution

    US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.

    Quantity

    113,843 kits