BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272

    Recall: Z-1849-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1849-2026
    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) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272

    Reason

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Code Info

    1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 10193489493184(each), 40193489493185(case), Lot Number: 24KBG704; 3) DYNJ51935A, UDI-DI: 10889942735549(each), 40889942735540(case), Lot Number: 24BME364; 4) DYNJ68902A, UDI-DI: 10193489870411(each), 40193489870412(case), Lot Number: 24BMC999; 5) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 22KBJ690; 6) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23BBD696; 7) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23DBG588; 8) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23FBD221; 9) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23GBN050; 10) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23IBB710; 11) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23LBM277; 12) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24CBN011; 13) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24DBK248; 14) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24GBC694; 15) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24HBX136; 16) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 24IBR538; 17) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 25ABC728; 18) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 25CBE147; 19) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 25CBP816; 20) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23JBS196; 21) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 25EBM284; 22) DYNJ82370A, UDI-DI: 10198459220227(each), 40198459220228(case), Lot Number: 25BBT096; 23) DYNJ82370A, UDI-DI: 10198459220227(each), 40198459220228(case), Lot Number: 25DBO043; 24) DYNJ84272, UDI-DI: 10195327349882(each), 40195327349883(case), Lot Number: 24KBE401; 25) DYNJ84272, UDI-DI: 10195327349882(each), 40195327349883(case), Lot Number: 25BBO542

    Distribution

    US Nationwide distribution.

    Quantity

    2609 units