BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

    Recall: Z-1833-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1833-2026
    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) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

    Reason

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Code Info

    1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22IBH073; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22IBH620; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22KBU236; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22LBB186; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBE163; 6) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBQ244; 7) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23BBT094; 8) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23CBN156; 9) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23DBO047; 10) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23EBN965; 11) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23FBG730; 12) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23HBL275; 13) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24BBT133; 14) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24DBC913; 15) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24DBM253; 16) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24EBD055; 17) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24EBM619; 18) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24FBC811; 19) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24GBO792; 20) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24HBQ429; 21) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24KBO162; 22) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25ABL984; 23) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25ABV250; 24) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBC496; 25) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBS716; 26) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25BBU979; 27) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBB632; 28) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBC880; 29) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25CBN329; 30) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 22JBU981; 31) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 23FBP998; 32) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 24JBO656; 33) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25DBR721; 34) VASCSLPOFF1, UDI-DI: 10889942405527(each), 40889942405528(case), Lot Number: 24KBI875; 35) VASCSLPOFF1, UDI-DI: 10889942405527(each), 40889942405528(case), Lot Number: 23KBD992; 36) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25BBG137; 37) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25BBI161; 38) VASC1018A, UDI-DI: 10889942337033(each), 40889942337034(case), Lot Number: 25ABG686

    Distribution

    US Nationwide distribution.

    Quantity

    58836 units