BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G

    Recall: Z-2421-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2421-2026
    Event ID
    98951
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2026
    Initiation Date
    April 27, 2026
    Classification Date
    June 12, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD AND NECK MHS DYNJ905364B MAJOR EAR CDS983347S MAJOR EAR FMOL LADY OF THE LAK DYNJ89581 MAJOR EAR PACK DYNJT4872 MAJOR HEAD AND NECK PACK DYNJ38985G MAJOR HEAD NECK PACK DYNJ45706B MZ EAR CDS DYNJ905642F PARATHYROID PACK DYNJ81389F PK,ENT-EAR DYNJ43700B SM-HEAD AND NECK PACK-LF DYNJ0780036W THYROID CDS CDS983693I TYMPANOPLASTY CDS982720S TYMPANOPLASTY MASTOIDECTOM DYNJ66231B TYMPANOPLASTY PACK-LF DYNJ62820D WH FACIAL HEAD AND NECK PACK DYNJ89028A WMC COCHLEAR IMPLANT ADD ON DYNJ907206G

    Reason

    Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

    Code Info

    DYNJ86476B UDI-DI 10198459440366 Lot 25KBL478 DYNJ81460C UDI-DI 10198459434679 Lot 25KBE552 DYNJ900004J UDI-DI 10198459560354 Lot 26AMA112 DYNJ901779J UDI-DI 10193489979749 Lot 25LMI890 DYNJ902900F UDI-DI 10198459496936 Lot 25KBA607 DYNJ81419D UDI-DI 10198459113444 Lot 25KBM670 DYNJ40498B UDI-DI 10193489806779 Lots 25KBC776 25LBO494 DYNJ901246J UDI-DI 10198459447310 Lots 25KBQ989 26ABI798 26DBH373 DYNJ909252C UDI-DI 10198459318726 Lots 25JBS227 25KBC598 25LBR040 DYNJ909255C UDI-DI 10198459210167 Lot 25LBH411 DYNJ905364B UDI-DI 10198459346255 Lots 25LBM363 26BBO336 CDS983347S UDI-DI 10198459397370 Lots 26BBC029 26CBR342 DYNJ89581 UDI-DI 10198459278594 Lot 25LBP819 DYNJT4872 UDI-DI 10198459459672 Lot 25KBA908 DYNJ38985G UDI-DI 10195327385682 Lots 25JBA164 25KBG575 DYNJ45706B UDI-DI 10193489856293 Lot 25KBK200 DYNJ905642F UDI-DI 10195327587277 Lot 26AME607 DYNJ81389F UDI-DI 10198459394775 Lot 26BBC753 DYNJ43700B UDI-DI 10195327523039 Lot 25LBD750 DYNJ0780036W UDI-DI 10198459036972 Lot 25LMJ600 CDS983693I UDI-DI 10193489953848 Lot 25KBQ399 CDS982720S UDI-DI 10198459530258 Lots 25KBU081 25LBT481 26ABC446 DYNJ66231B UDI-DI 10195327341640 Lots 25JBY408 25KBK197 DYNJ62820D UDI-DI 10198459105463 Lot 25LMH554 DYNJ89028A UDI-DI 10198459472565 Lot 25KBI158 DYNJ907206G UDI-DI 10198459368028 Lot 25LBM564

    Distribution

    US Nationwide distribution. OUS distribution pending.

    Quantity

    49,654 kits total