Class 2 Device Recall Medline

• Date Initiated by Firm: April 27, 2026
• Date Posted: June 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2441-2026
• Recall Event ID: 98951
• 510(K)Number: K213481
• Product Classification: General surgery tray - Product Code LRO
• Product: 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
• Code Information: DYNJ64161C UDI-DI 10198459146961 Lot 25KBH332 DYNJ47103D UDI-DI 10198459625008 Lot 25LMF684 DYNJ67197G UDI-DI 10198459481994 Lot 25JBA258 DYNJ85197A UDI-DI 10198459217395 Lot 25LMF727 DYNJT4007 UDI-DI 10198459381867 Lot 26BBC180 DYNJ36698B UDI-DI 10198459081811 Lots 25KBM204 26CBD413 DYNJ89037 UDI-DI 10198459229855 Lots 25KBI083 25KBM202 DYNJ0171446I UDI-DI 10195327589516 Lot 25JBT239 DYNJ0171446J UDI-DI 10198459591754 Lot 26CBB295 DYNJ910915A UDI-DI 10198459424960 Lot 25LBD596 DYNJ87587A UDI-DI 10198459114199 Lot 25JBR735 DYNJ84482C UDI-DI 10198459362491 Lot 26BBU043 DYNJ49172I UDI-DI 10198459042003 Lot 26AMA388 DYNJ48013L UDI-DI 10198459560941 Lot 25LBP624 DYNJ0220136S UDI-DI 10198459566073 Lot 25LMF648 DYNJ908135B UDI-DI 10198459586552 Lots 25LBC200 25LBR878 DYNJ53044G UDI-DI 10198459448768 Lot 25LMG369 DYNJ909099F UDI-DI 10198459375996 Lot 25JMF136 DYNJ61711C UDI-DI 10198459096754 Lot 25JBT124 DYNJ20010L UDI-DI 10198459229053 Lot 25JMD853 DYNJ64964J UDI-DI 10198459254109 Lot 25LMI867 DYNJ43210K UDI-DI 10198459546792 Lot 25LMI070 DYNJ61787F UDI-DI 10198459169694 Lot 25JBU635 DYNJ87065 UDI-DI 10198459007439 Lots 25KBD819 25LBP631 DYNJ82564A UDI-DI 10198459497551 Lot 25LBD560 DYNJ54720D UDI-DI 10195327549510 Lot 26CBC228 DYNJ54722F UDI-DI 10195327549633 Lots 25KBB967 25LBQ696 26CBE680 DYNJ83095B UDI-DI 10198459562068 Lot 25JMD325 DYNJ32934F UDI-DI 10195327697181 Lot 26CBC762 DYNJ68935B UDI-DI 10198459440373 Lot 25LBN254 DYNJ66502B UDI-DI 10198459395321 Lot 25KBC481 DYNJ66252F UDI-DI 10198459185397 Lot 25LBP873 DYNJT8381 UDI-DI 10198459702358 Lot 26CBD354 DYNJ34580D UDI-DI 10195327579661 Lot 25LMF989 DYNJ0282388T UDI-DI 10198459591990 Lot 25LBP896 DYNJ88308 UDI-DI 10198459143328 Lot 25KBJ822 DYNJ907120D UDI-DI 10198459427985 Lots 25KBK051 25KBT376 26DBF975 DYNJ58404F UDI-DI 10198459366413 Lots 25KBI176 26CBE677 DYNJ84740A UDI-DI 10198459421556 Lot 25KBB657 DYNJ46531Q UDI-DI 10198459526107 Lot 25LMJ845 DYNJT5271 UDI-DI 10198459471452 Lot 25LBC165 DYNJ68785D UDI-DI 10198459546952 Lot 25JBU924 DYNJT6005 UDI-DI 10198459531187 Lot 25JBU086 DYNJ82087A UDI-DI 10198459078019 Lot 25LMH034 DYNJ83939C UDI-DI 10198459342523 Lot 25JBY263 DYNJ39217P UDI-DI 10198459102356 Lot 25JME213 DYNJ0578916AA UDI-DI 10198459117565 Lot 25JME873 DYNJ58528J UDI-DI 10198459322815 Lot 26CBE343 DYNJ61661B UDI-DI 10198459096785 Lot 25KBA722 DYNJ0753436P UDI-DI 10198459466854 Lot 25LMJ282 DYNJ54968B UDI-DI 10198459428753 Lot 25KBD827 DYNJ67628D UDI-DI 10198459383373 Lot 25LMG428 DYNJ0578815W UDI-DI 10198459466892 Lot 25LMI628 DYNJ54400C UDI-DI 10195327646905 Lot 25KBI070 DYNJT5008 UDI-DI 10198459463525 Lot 26BBC492 DYNJ48260F UDI-DI 10198459220241 Lot 25KBL822 DYNJ39247I UDI-DI 10195327633509 Lot 25JBR808 DYNJ39247J UDI-DI 10198459640698 Lot 26BBD397 DYNJ31461I UDI-DI 10198459519734 Lot 25JBV372 DYNJ61411C UDI-DI 10198459493591 Lot 25KBA043 DYNJ65471B UDI-DI 10198459168574 Lot 25JMF211 DYNJ45373G UDI-DI 10198459254635 Lot 25LMI203 DYNJ82495D UDI-DI 10198459439834 Lots 25KBI927 25LBR381 DYNJ62433F UDI-DI 10198459627514 Lot 25LBO801 OP7809M UDI-DI 10198459368493 Lot 26CBB615 DT13351A UDI-DI 10653160325581 Lots 25JBA293 25KBB632 DYNJ84120C UDI-DI 10198459574177 Lot 26AMA032 ARTNC234 UDI-DI 10198459566974 Lot 25KBJ985 DYNJT5376 UDI-DI 10198459470783 Lot 25LBP929 DYNJ47978G UDI-DI 10198459416606 Lot 26AMA586 DYNJ62643B UDI-DI 10198459164446 Lot 25LMG407 DYNJ58410D UDI-DI 10198459366468 Lot 25LBI975 DYNJ54477C UDI-DI 10198459004155 Lot 25LMI210 DYNJT8391 UDI-DI 10198459703140 Lot 26CBJ555 DYNJ61052B UDI-DI 10198459421587 Lot 26BBC156 DYNJT3266 UDI-DI 10198459320965 Lot 25LMH283 DYNJ0122428K UDI-DI 10198459533297 Lot 25EBP843A PHS656414I UDI-DI 10198459006258 Lot 25LMG515 DYNJ64949C UDI-DI 10198459190216 Lot 25LMH829 DYNJ83649B UDI-DI 10198459110177 Lot 25KBC046 DYNJ47104D UDI-DI 10198459624964 Lot 25LMJ846 DYNDA2664 UDI-DI 10193489342635 Lots 25JBT011 26CBD503 DYNJ84741B UDI-DI 10198459421563 Lot 25KBC487 DYNJ68253F UDI-DI 10198459185366 Lot 25KBA720 DYNJ83246B UDI-DI 10195327665463 Lots 25KBN031 25LBQ952 DYNJT6993 UDI-DI 10198459588211 Lot 25KBI629 DYNJ0509186J UDI-DI 10198459117626 Lot 25LMI076 CDS983181G UDI-DI 10198459038174 Lot 25LBA047
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-633-5463
• Manufacturer Reason for Recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 49,654 kits total
• Distribution: US Nationwide distribution. OUS distribution pending.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LRO