{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218739", "product_res_number": "Z-1562-2026", "event_date_initiated": "2026-01-30", "event_date_posted": "2026-03-12", "recall_status": "Open, Classified", "res_event_number": "98437", "product_code": "OEZ", "product_description": "Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit:\n1) OPEN HEART, Model Number: DYNJ902487A; \n2) CARDIAC PROCEDURE, Model Number: DYNJ908126; \n3) CARDIO CONGENITO, Model Number: DYNJ910851", "code_info": "1) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22KMG297;\n2) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 22FMA481;\n3) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21IMG797;\n4) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMG569;\n5) DYNJ902487A, UDI-DI: 10193489496635(each), 40193489496636(case), Lot Number: 21HMB801;\n6) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 26ABL637;\n7) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467M;\n8) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBN467;\n9) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25JBG183;\n10) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25HBF488;\n11) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25GBK350;\n12) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25FBO822;\n13) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBT976;\n14) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP602;\n15) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP589;\n16) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP588;\n17) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP587;\n18) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25EBP586;\n19) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25DBB810;\n20) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 25ABA001;\n21) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24HBM020;\n22) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24GBC436;\n23) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24FBS256;\n24) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBP532;\n25) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24BBA256;\n26) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 24ABN040;\n27) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBP214;\n28) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23JBJ077;\n29) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23IBQ646;\n30) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23HBU475;\n31) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE710;\n32) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23GBE709;\n33) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23FBF593;\n34) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBJ852;\n35) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 23DBC954;\n36) DYNJ908126, UDI-DI: 10193489980110(each), 40193489980111(case), Lot Number: 22KBO714;\n37) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25IBK435;\n38) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBT069;\n39) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBO806;\n40) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25HBH137;\n41) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 25GBA989;\n42) DYNJ910851, UDI-DI: 10198459155895(each), 40198459155896(case), Lot Number: 24LBJ019", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "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.", "root_cause_description": "Error in labeling", "action": "An URGENT MEDICAL DEVICE PRODUCT ADVISORY notification dated 1/30/25 was sent to customers.\n\nREQUIRED ACTION:\n1.Actions to be taken are indicated on the attached recall notification from Cardinal Health.\n2.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.\nWebsite link: https://recalls.medline.com\nRecall Reference #: R-26-006-FGX2\nRecall Code: \n3.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.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "2894 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.", "openfda": { "registration_number": [ "1422634", "1643817", "1043214", "3014925393", "3017987980", "3002807314", "3035642068", "2029015", "3015225571", "3015173212", "1124841", "3004911384", "1721504", "3015910259", "3006950086", "3012536737", "1054241", "3015309643", "3009337401", "1319639", "3004122598", "3011642792", "1047429", "3002124543", "1928237", "1724474", "1123137", "1125782", "3018044766", "3018077422", "1721676", "1221108", "3011144486", "3010532612", "9616099", "3004111573", "2124215", "3007289408", "3033589330", "3007329020", "1030451", "3013162291", "3005595283", "1061124", "3045816902", "1016427", "1055236", "3032507796", "3015053858", "9680794", "9616088", "1423395", "3009888344", "3024985933", "1423537", "1625425", "3010155661", "3004519921", "3026197444", "3005012805", "3009203853" ], "fei_number": [ "1000512168", "1643817", "1000123180", "1043214", "1000138054", "3001236905", "3014925393", "3017987980", "3003094851", "3002807314", "3005846326", "3035642068", "3015225571", "3015173212", "3004911384", "1721504", "3002902735", "3015910259", "3006950086", "3012536737", "1000112968", "3015309643", "1000112877", "3000204839", "3009337401", "3004122598", "3011642792", "1047429", "3002124543", "3003528016", "1928237", "3018044766", "3018077422", "1721676", "1221108", "3011144486", "3010532612", "2124215", "3004111573", "3007289408", "3033589330", "3007329020", "1030451", "3000717925", "3013162291", "3002975287", "3005595283", "3045816902", "1016427", "3032507796", "3015053858", "1000514656", "3009888344", "3024985933", "1625425", "3003737899", "1000160458", "3010155661", "3026197444", "3005012805", "3009203853" ], "device_name": "Cardiovascular Procedure Kit", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ] }