Class 2 Device Recall Medline

• Date Initiated by Firm: April 27, 2026
• Date Posted: June 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2424-2026
• Recall Event ID: 98951
• Product Classification: General surgery tray - Product Code LRO
• Product: Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY PA DYNJ58305 CHRISTUS CH PEDIATRIC BASIC DYNJ61167G CVC INSERTION BUNDLE CVI3940A DAVINCI PACK SURGICOUNT DYNJ45544F EPCH BASIC PACK DYNJ83094C GENERAL PACK DYNJ39682B DYNJ84882 GENERAL RFD DYNJ906336F GENERAL SURGERY PACK DYNJT6003 GV MACD PACK DYNJ46952M IMPLANT PACK - BBI AR DYNJ63508A KIT THORACOSCOPY DYNJ908872F LVAD TRAY DM1120A MAJOR UROLOGY PACK-LF DYNJ0368525M MICRODISECT DECOMPRESS-LF DYNJ911467 MINOR PACK DYNJ86972 MULTI PURPOSE PACK DYNJ58406B OPEN HEART DYNJ903245C P&K PACK DYNJT5838 PACK,PEDIATRIC MAJOR DYNJ906888F PCNL DYNJ904468C PEDIATRIC MINOR RFD DYNJ906296I PEDIATRIC PACK DYNJ54239K PEDIATRIC SURGERY DYNJ81474B PERLMUTTER PACK DYNJT7387 RFT ISC NOBLES MINOR PACK DYNJ43954B ROBOTICS FMOL LADY OF THE LAKE DYNJ89584 ROBOTICS PACK DYNJ83622B SCOLI PACK NTX DYNJ68415C SMALL ABDOMINAL PACK-LF PHS41749G STIM IMPLANT TRIALS DYNJ87790A SUPPLEMENTAL PACK DYNJ65244 TENEX PACK DYNDH2190 THORACIC PACK DYNJ56616G THORACIC PACK SHD DYNJ68416C THORACOSCOPY DYNJ9425843R THORACOTOMY PM DYNJ906815A THORACOTOMY THORACOSCOPY DYNJ902882D TRAY,NEONATAL PICC DRSG CHANGE DYNDC1533B UNIVERSAL-ASC DYNJ900071C
• Code Information: DYNJ905869G UDI-DI 10198459394577 Lot 25JBX559 DYNJ68484B UDI-DI 10198459368967 Lot 25LME889 DYNJ58305 UDI-DI 10889942843763 Lot 25KBA708 DYNJ61167G UDI-DI 10198459386671 Lots 25KBN904 25LBQ928 CVI3940A UDI-DI 10653160998976 Lot 26AME675 DYNJ45544F UDI-DI 10193489876130 Lot 25KBJ042 DYNJ83094C UDI-DI 10198459562051 Lot 25JMD330 DYNJ39682B UDI-DI 10193489769241 Lots 25KBI410 25LBI978 26BBC735 DYNJ84882 UDI-DI 10195327432324 Lot 26CBQ487 DYNJ906336F UDI-DI 10198459419959 Lots 25KBR497 26CBO946 DYNJT6003 UDI-DI 10198459531255 Lots 25JBV850 26CBC211 DYNJ46952M UDI-DI 10198459090134 Lots 25KBH401 25LBO238 DYNJ63508A UDI-DI 10193489363845 Lot 26BBC181 DYNJ908872F UDI-DI 10198459660306 Lot 26BBR620 DM1120A UDI-DI 10653160998891 Lots 25KBA425 25LBJ075 DYNJ0368525M UDI-DI 10193489820249 Lots 25KBG895 25KBG896 DYNJ911467 UDI-DI 10198459358562 Lot 25LBA393 DYNJ86972 UDI-DI 10195327694296 Lot 26CBD230 DYNJ58406B UDI-DI 10193489957228 Lot 25JBT217 DYNJ903245C UDI-DI 10889942890170 Lot 26ABG614 DYNJT5838 UDI-DI 10198459513329 Lot 25JBT808 DYNJ906888F UDI-DI 10198459194764 Lot 26AMC879 DYNJ904468C UDI-DI 10195327631413 Lot 25KBL838 DYNJ906296I UDI-DI 10198459419829 Lot 25KBN303 DYNJ54239K UDI-DI 10198459443206 Lot 25LMG373 DYNJ81474B UDI-DI 10198459100260 Lot 25JBY253 DYNJT7387 UDI-DI 10198459615924 Lot 26CBQ932 DYNJ43954B UDI-DI 10193489509168 Lot 25LMI928 DYNJ89584 UDI-DI 10198459278723 Lots 25JBS433 25LBO815 25LBP820 DYNJ83622B UDI-DI 10198459402739 Lots 25JBA251 25JBX613 DYNJ68415C UDI-DI 10195327341749 Lots 25KBM185 26BBD267 PHS41749G UDI-DI 10198459438844 Lot 25LMG971 DYNJ87790A UDI-DI 10198459358968 Lots 25KBC718 25KBC975 DYNJ65244 UDI-DI 10193489257434 Lots 25KBC479 26CBC173 DYNDH2190 UDI-DI 10198459467967 Lots 25KBE086 25KBM732 DYNJ56616G UDI-DI 10198459533167 Lots 25LBD705 26CBC585 DYNJ68416C UDI-DI 10195327341688 Lot 25KBH744 DYNJ9425843R UDI-DI 10198459085499 Lot 25KMC242 DYNJ906815A UDI-DI 10195327027018 Lot 26BBO802 DYNJ902882D UDI-DI 10198459496790 Lot 25LBR117 DYNDC1533B UDI-DI 10889942813926 Lot 25JBU460 DYNJ900071C UDI-DI 10198459121722 Lots 26AMH365 26AMH758
• 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.