Class 2 Device Recall Medline

• Date Initiated by Firm: February 27, 2026
• Date Posted: June 25, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2592-2026
• Recall Event ID: 99062
• Product Classification: Cardiac catheterization kit - Product Code OES
• Product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A
• Code Information: DYNJ47665D UDI-DI 10193489952827 Lots 21HBJ571 21JBD819 21LBA976 22BBP310 22CBW541 22CMH003 22DMD476 22EMA241 22FMF056 22HMC694 22HME818 22IMC158 22IMG796 22JMD311 22LMD944 22NBC196 23AMB219 DYNJ30565D UDI-DI 10193489905205 Lots 21FDB653 21GDB275 DYNJ0854485V UDI-DI 10195327096885 Lots 22CMB440 22EMF763 22HMA699 22HMG186 22IMD134 22LME930 23BMC883 23CMB807 23CMI020 DYNJ28082D UDI-DI 10193489268676 Lots 21ABN806 21BBP110 21DBL217 21EBS784 21FBU514 DYNJ28082F UDI-DI 10193489949452 Lots 21HBM290 21IBQ174 21KBO096 21KBO098 DYNJ67349 UDI-DI 10193489895728 Lots 23JMA721 24BMF147 DYNJ57874C UDI-DI 10193489976618 Lot 24ABM611 DYNJSCL100 UDI-DI 10884389625583 Lot 24ABM801 DYNJSCL300 UDI-DI 10884389625606 Lot 24ABM802 DYNJ50779F UDI-DI 10193489436068 Lots 21DME914 21EMF097 21GMB502 21JMA420 22BMA533 22BMB246 22DMA002 22DMD984 22DMI243 22EMG746 22GMB725 22HMH063 22IME310 22KMA626 23AME217 23BME137 23DMH595 23EMI849 23FMJ773 23JMB530 23LMH087 24BMF696 24CMJ355 24DMA986 DYNJ41088B UDI-DI 10889942632794 Lot 21ABG127 DYNJ48085 UDI-DI 10888277546035 Lot 24AMF987 DYNJ37389N UDI-DI 10193489306019 Lots 21ABN379 21CBU277 21DBP810 DYNJ37389O UDI-DI 10193489925302 Lots 21FBL377 21GBD005 21HBN337 21JBW141 21JBW142 21LBG627 22ABH544 22CBF313 22DBD511 22DBE512 22FBS027 DYNJ62595A UDI-DI 10193489364262 Lots 21ABH085 21ABI181 21ABV975 21BBO277 21CBU091 21EBA810 DYNJ69997 UDI-DI 10195327004743 Lots 22DBK793 22IBD718 22IBE297 22OBC253 DYNJ47645B UDI-DI 10193489952834 Lots 21GBM457 21IBV915 21KBF627 21LBA512 21LME436 22DMI445 22EMD836 22FMC418 22GME258 22KMD663 DYNJ67918A UDI-DI 10195327042776 Lots 21LBP804 22CBZ026 22CBZ027 22OBG779 DYNJ56666C UDI-DI 10193489876079 Lots 21GMD986 21IMF632 21KMI417 22BMG174 22EMC819 22GMA609 22HMB858 22IME607 22JMI267 22LMA954 22LMH272 23BMH725 DYNJ44100L UDI-DI 10193489808810 Lots 20LMF752 21AMD830 21BMB938 21DMB287 21FMA141 21GMF673 21HMF024 21JMH879 21LMD528 22AME658 22CMD992 22DME753 22EMI131 22FMD999 22GMA910 22HMG804 22KMC260 22LMF595 DYNJ43664 UDI-DI 10888277065475 Lot 22FBP452 DYNJ0516014AF UDI-DI 10193489346978 Lots 21ABD076 21FBH595 21HBP277 21IBX390 21KBK660 22BBF662 22CBA986 22CBQ787 22DBI149 22FMC751 22FMF379 22IMA038 22IMH722 DYNJ907758A UDI-DI 10193489978384 Lot 21KBQ655 DYNJ62376A UDI-DI 10193489933598 Lot 24ABP679
• 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: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
• FDA Determined Cause: No Marketing Application
• Action: This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA. Firm began notifying customers on February 27, 2026 via letters titled "URGENT MEDICAL DEVICE RECALL". Customers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.
• Quantity in Commerce: 113, 843 kits
• Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
• 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.