BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817

    Recall: Z-1844-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1844-2026
    Event ID
    98599
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2026
    Initiation Date
    February 25, 2026
    Classification Date
    April 17, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817

    Reason

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Code Info

    1) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23DBP927; 2) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23EBS362; 3) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25DBM593; 4) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25GBO740; 5) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23LBU617; 6) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23HBK865; 7) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24BMC721; 8) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24EMF715; 9) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24AMI140; 10) DYNJ63779A, UDI-DI: 10193489355840(each), 40193489355841(case), Lot Number: 25HBM008; 11) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 24HBF527; 12) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25BBL663; 13) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25CBN143; 14) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25EBJ520; 15) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25FBC657

    Distribution

    US Nationwide distribution.

    Quantity

    9645 units