Class 2 Device Recall Medline

• Date Initiated by Firm: February 27, 2026
• Date Posted: June 25, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2582-2026
• Recall Event ID: 99062
• Product Classification: Cardiac catheterization kit - Product Code OES
• Product: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B
• Code Information: DYNJ43609S UDI-DI 10195327322984 Lot 23BMG740; DYNJ67987D UDI-DI 10195327265496 Lot 22LMI014; DYNJ80317A UDI-DI 10195327410780 Lot 23JLA076 DYNJ38412C UDI-DI 10195327291792 Lot 24CME277 DYNJ66260A UDI-DI 10195327185749 Lot 22GMH445 DYNJ44293I UDI-DI 10198459152108 Lots 24JBX196 24KBJ077 24LBF062 24LBP058 DYNJ0854485W UDI-DI 10195327403430 Lot 23EMI244 DYNJ82709 UDI-DI 10195327202590 Lots 22KBG072 23ABM307 23ABR612 DYNJ0261554AL UDI-DI 10195327467760 Lot 23IMA846 DYNJ31103F UDI-DI 10195327461317 Lots 23ILA143 23JLA420 23KLB055 23LLA790 24ALA692 24BLA009 24BLA835 24CLA859 24ELA213 24ELA684 24FLA287 24GLA266 24HLA117 24HLB121 24JLA570 24KLB094 24LLA468 25ALA377 DYNJ83506 UDI-DI 10195327272890 Lot 22LBM317 DYNJ66366C UDI-DI 10195327232887 Lots 22HME111 22IME517 22JMF050 22LMH296 23DMD313 23EMF238 23FMH270 23GMF506 23HME060 SAMPC0686 UDI-DI 10195327195489 Lot 22HDA577 DYNJ63434B UDI-DI 10195327335502 Lots 23CBG406 23CBU167 23DBT002 23EBS228 DYNJ907758B UDI-DI 10195327181000 Lot 22GBD778 DYNJ80925B UDI-DI 10195327624903 Lot 24CBG978
• 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.