BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O

    Recall: Z-2431-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2431-2026
    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: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O

    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

    DYNJ905836D UDI-DI 10195327517977 Lot 25LBB534 DYNJ905293I UDI-DI 10198459247972 Lot 25KBM585 DYNJT8308 UDI-DI 10198459697135 Lot 26CBD040 CDS860087Q UDI-DI 10198459543005 Lots 25JBV094 25LBP061 DYNJ910084C UDI-DI 10198459597466 Lot 25LBE810 CDS982371I UDI-DI 10198459044106 Lots 25KBH343 26CBN241 CDS920099S UDI-DI 10195327140656 Lot 25KBO172 DYNJT3887 UDI-DI 10198459366871 Lot 25JBX564 DYNJT6876 UDI-DI 10198459583148 Lot 25KBM646 CDS984228K UDI-DI 10198459044113 Lot 26ABF608 DYNJ911843 UDI-DI 10198459555206 Lot 25LBC203 DYKMBNDL165C UDI-DI 10198459634284 Lot 25LBR024 CDS985442J UDI-DI 10198459476686 Lot 25JBT926 DYNJ84725B UDI-DI 10198459366949 Lot 25JBA329 DYNJ910594B UDI-DI 10198459563768 Lot 25KBJ104 DYNJ53711B UDI-DI 10198459023538 Lots 25KBF929 25LBB875 DYNJ83622C UDI-DI 10198459607172 Lots 25LBR740 26CBJ460 DYNJ909322B UDI-DI 10198459443848 Lot 25LBD961 DYNJ902583O UDI-DI 10198459441806 Lot 25LBC041

    Distribution

    US Nationwide distribution. OUS distribution pending.

    Quantity

    49,654 kits total