BEUDAMED
    FDA Recall Open, Classified

    Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICAL FUSION DYNJ908135B CERVICAL SPINE PACK DYNJ53044G C-SECTION DYNJ909099F DAVINCI PROSTATE PACK DYNJ61711C DEPAUL FOOT & ANKLE-LF DYNJ20010L DIEP PACK DYNJ64964J DYNJ43210K DYNJ61787F DYNJ87065 EAR CUSTOM PACK DYNJ82564A ENT FREE FLAP PACK SAFETY DYNJ54720D EP PACEMAKER SAFETY #1 DYNJ54722F EPCH EXTREMITY PACK DYNJ83095B EXTREMITY PACK DYNJ32934F EXTREMITY PACK-LF DYNJ68935B FISTULA PACK DYNJ66502B GENDER AFFIRMING SURGERY DYNJ66252F GYN LAPAROSCOPY PACK AHSC DYNJT8381 HAND PACK WATCHMAKER-LF DYNJ34580D HEAD & NECK PACK-LF DYNJ0282388T DYNJ88308 HIP SCOPE DYNJ907120D KNEE ARTHRO PACK DYNJ58404F KNEE ARTHROSCOPY PACK DYNJ84740A LAMI OVERHEAD PACK DYNJ46531Q LAMINECTOMY NEURO MPH DYNJT5271 LAMINECTOMY PACK DYNJ68785D LAP APPY PACK DYNJT6005 LAP CHOLE PACK DYNJ82087A LEVY PACK DYNJ83939C MAJOR LAP VCH DYNJ39217P MAJOR NEURO PACK-LF DYNJ0578916AA MAJOR PACK DYNJ58528J MINOR GEN PACK DYNJ61661B MINOR LAPAROTOMY PACK-LF DYNJ0753436P MINOR PACK DYNJ54968B NEURO PACK DYNJ67628D NEURO SHUNT PACK-LF DYNJ0578815W OMFS PACK DYNJ54400C OPEN HEART PACK DYNJT5008 OPEN HEART-LF DYNJ48260F OPEN LAPAROTOMY PACK DYNJ39247I DYNJ39247J PACEMAKER PACK DYNJ31461I DYNJ61411C PACK,ORTHO FLIP DYNJ65471B PED OPEN HEART PACK DYNJ45373G PLASTIC PACK DYNJ82495D PLASTICS PK - NO SYR DYNJ62433F PODIATRY PACK OP7809M PPE BUNDLE KIT DT13351A PROSTATE ROBOTIC PACK DYNJ84120C RADIAL ART LINE INSERTION ARTNC234 ROBOTIC GENERAL WHH DYNJT5376 ROBOTIC PACK DYNJ47978G RR-SPINE PACK DYNJ62643B SHOULDER ARTH PACK DYNJ58410D SHOULDER ARTHROSCOPY PACK DYNJ54477C DYNJT8391 SHOULDER PACK DYNJ61052B DYNJT3266 SHOULDER PACK-LF DYNJ0122428K PHS656414I SPINE PACK DYNJ64949C DYNJ83649B SPINE SHOULDER PACK DYNJ47104D STERILE ACCESS KIT DYNDA2664 TOTAL KNEE PACK DYNJ84741B TUBAL PACK DYNJ68253F UNIVERSAL PACK DYNJ83246B VA TAMPA GENERAL ROBOTIC PACK DYNJT6993 W.C. MINOR LAPAROTOMY PK-LF DYNJ0509186J ZALE OTOLOGY CDS CDS983181G

    Recall: Z-2441-2026 · Initiated April 27, 2026

    Recall

    Recall Number
    Z-2441-2026
    Event Number
    98951
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 27, 2026
    Posted
    June 12, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007 BASIC ACCESS PACK-LF DYNJ36698B BASIC BACK TRAY DYNJ89037 BASIC PEDI PACK-LF DYNJ0171446I DYNJ0171446J BASIC SPINE DYNJ910915A BREAST PACK DYNJ87587A BREAST PLASTIC PACK DYNJ84482C C SECTION DYNJ49172I CAROTID ENDARTERECTOMY PACK DYNJ48013L CENTRAL LINE PACK-LF DYNJ0220136S CERVICAL FUSION DYNJ908135B CERVICAL SPINE PACK DYNJ53044G C-SECTION DYNJ909099F DAVINCI PROSTATE PACK DYNJ61711C DEPAUL FOOT & ANKLE-LF DYNJ20010L DIEP PACK DYNJ64964J DYNJ43210K DYNJ61787F DYNJ87065 EAR CUSTOM PACK DYNJ82564A ENT FREE FLAP PACK SAFETY DYNJ54720D EP PACEMAKER SAFETY #1 DYNJ54722F EPCH EXTREMITY PACK DYNJ83095B EXTREMITY PACK DYNJ32934F EXTREMITY PACK-LF DYNJ68935B FISTULA PACK DYNJ66502B GENDER AFFIRMING SURGERY DYNJ66252F GYN LAPAROSCOPY PACK AHSC DYNJT8381 HAND PACK WATCHMAKER-LF DYNJ34580D HEAD & NECK PACK-LF DYNJ0282388T DYNJ88308 HIP SCOPE DYNJ907120D KNEE ARTHRO PACK DYNJ58404F KNEE ARTHROSCOPY PACK DYNJ84740A LAMI OVERHEAD PACK DYNJ46531Q LAMINECTOMY NEURO MPH DYNJT5271 LAMINECTOMY PACK DYNJ68785D LAP APPY PACK DYNJT6005 LAP CHOLE PACK DYNJ82087A LEVY PACK DYNJ83939C MAJOR LAP VCH DYNJ39217P MAJOR NEURO PACK-LF DYNJ0578916AA MAJOR PACK DYNJ58528J MINOR GEN PACK DYNJ61661B MINOR LAPAROTOMY PACK-LF DYNJ0753436P MINOR PACK DYNJ54968B NEURO PACK DYNJ67628D NEURO SHUNT PACK-LF DYNJ0578815W OMFS PACK DYNJ54400C OPEN HEART PACK DYNJT5008 OPEN HEART-LF DYNJ48260F OPEN LAPAROTOMY PACK DYNJ39247I DYNJ39247J PACEMAKER PACK DYNJ31461I DYNJ61411C PACK,ORTHO FLIP DYNJ65471B PED OPEN HEART PACK DYNJ45373G PLASTIC PACK DYNJ82495D PLASTICS PK - NO SYR DYNJ62433F PODIATRY PACK OP7809M PPE BUNDLE KIT DT13351A PROSTATE ROBOTIC PACK DYNJ84120C RADIAL ART LINE INSERTION ARTNC234 ROBOTIC GENERAL WHH DYNJT5376 ROBOTIC PACK DYNJ47978G RR-SPINE PACK DYNJ62643B SHOULDER ARTH PACK DYNJ58410D SHOULDER ARTHROSCOPY PACK DYNJ54477C DYNJT8391 SHOULDER PACK DYNJ61052B DYNJT3266 SHOULDER PACK-LF DYNJ0122428K PHS656414I SPINE PACK DYNJ64949C DYNJ83649B SPINE SHOULDER PACK DYNJ47104D STERILE ACCESS KIT DYNDA2664 TOTAL KNEE PACK DYNJ84741B TUBAL PACK DYNJ68253F UNIVERSAL PACK DYNJ83246B VA TAMPA GENERAL ROBOTIC PACK DYNJT6993 W.C. MINOR LAPAROTOMY PK-LF DYNJ0509186J ZALE OTOLOGY CDS CDS983181G

    Reason

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

    Action

    Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

    Distribution

    US Nationwide distribution. OUS distribution pending.

    Quantity

    49,654 kits total