Class 2 Device Recall Medline Procedure Kits

• Date Initiated by Firm: January 30, 2026
• Date Posted: March 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1562-2026
• Recall Event ID: 98437
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
• Code Information: 1) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22KMG297; 2) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22FMA481; 3) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21IMG797; 4) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMG569; 5) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMB801; 6) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 26ABL637; 7) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467M; 8) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467; 9) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBG183; 10) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25HBF488; 11) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25GBK350; 12) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25FBO822; 13) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBT976; 14) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP602; 15) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP589; 16) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP588; 17) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP587; 18) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP586; 19) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25DBB810; 20) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25ABA001; 21) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24HBM020; 22) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24GBC436; 23) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24FBS256; 24) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBP532; 25) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBA256; 26) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24ABN040; 27) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBP214; 28) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBJ077; 29) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23IBQ646; 30) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23HBU475; 31) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE710; 32) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE709; 33) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23FBF593; 34) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBJ852; 35) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBC954; 36) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 22KBO714; 37) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25IBK435; 38) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBT069; 39) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBO806; 40) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBH137; 41) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25GBA989; 42) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 24LBJ019
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
• FDA Determined Cause: Error in labeling
• Action: An URGENT MEDICAL DEVICE PRODUCT ADVISORY notification dated 1/30/25 was sent to customers. REQUIRED ACTION: 1.Actions to be taken are indicated on the attached recall notification from Cardinal Health. 2.Please use the link and the information below to complete your response form stating that you have received, read, understand and performed any actions as specified in the notification from CardinalHealth. Website link: https://recalls.medline.com Recall Reference #: R-26-006-FGX2 Recall Code: 3.If you are a distributor or have resold or transferred this product to another company or individual,you are required by FDA regulations to notify them of this communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 2894 units
• Distribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.
• 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.