{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221907", "product_res_number": "Z-3137-2026", "event_date_initiated": "2026-07-23", "event_date_posted": "2026-09-11", "recall_status": "Open, Classified", "res_event_number": "99583", "product_code": "LRO", "k_numbers": [ "K213481" ], "product_description": "Medline Convenience Kit:\r\nOPEN HEART A PACK, Product Number DYNJ43008N", "code_info": "UDI-DI: 10198459445941 (each), 40198459445942 (case);\nLot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372", "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 kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.", "root_cause_description": "Packaging process control", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 7/23/25 was sent to customers. \n\nREQUIRED ACTION:\n1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.\n2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.\nWebsite link: https://recalls.medline.com Recall Reference #: R-26-121-FGX1\nRecall Code: \n3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.\n4. 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 recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "135 units", "distribution_pattern": "US Nationwide distribution in the state of CA.", "openfda": { "k_number": [ "K882684", "K936117", "K964921", "K872448", "K910368", "K920267", "K931820", "K935686", "K874760", "K842648", "K965201", "K041080", "K952539", "K961683", "K971062", "K903336", "K913136", "K951149", "K854095", "K935743", "K925216", "K962826", "K925016", "K920292", "K963715", "K905004", "K933137", "K944044", "K901856", "K893814", "K923600", "K925467", "K961863", "K871437", "K023276", "K872011", "K924468", "K971061", "K890570", "K950574", "K930270", "K914935", "K902887", "K963443", "K871459", "K945831", "K931824", "K880942", "K945481", "K964011", "K934028", "K931760", "K902293", "K871322", "K930700", "K890726", "K892389", "K873973", "K970286", "K854292", "K932220", "K902888", "K932221", "K963721", "K910365", "K934688", "K030721", "K881083", "K934029", "K931844", "K871434", "K883250", "K931673", "K950295", "K945160", "K951478", "K914037", "K894685", "K926269", "K980137", "K970187", "K871873", "K935858", "K880961", "K884093", "K925214", "K890729", "K932652", "K931758", "K914174", "K941846", "K935740", "K932217", "K914036", "K931759", "K905459", "K213481", "K934030", "K895202", "K953083", "K922133", "K874439", "K890098", "K890658", "K885090", "K934428", "K922648", "K935483", "K212258", "K935741" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2", "registration_number": [ "3009637528", "1121203", "3002669946", "9680357", "3013298431", "9611024", "2648727", "3015058854", "3016761372", "3041276890", "3042480961", "3009888344", "3007829657", "3006400329", "3009750712", "3016096096", "3005595283", "3004605321", "2936485", "2431166", "3015173212", "2433012", "1650907", "3010376936", "1066741", "1644019", "3007329020", "3005246893", "3017430544", "2024311", "3010166880", "3013421458", "2029015", "3007289408", "1055236", "2000028362", "3027977504", "9616088", "3015895045", "1065597", "3002806603", "3017636737", "3012595397", "3006450239", "3002807314", "3006846316", "1823410", "1030451", "1047429", "2024980", "8030678", "1047843", "3005012805", "3014421917", "3045857302", "3006673317", "1061124", "3020983482", "3004911384", "1043214", "3007139365", "9681709", "1018470", "3011554160", "3003924117", "1060680", "3013600605", "8030672", "3009773841", "3014680744", "3007007790", "3010452421", "1424263", "1921846", "3035642068", "1422634", "3014718111", "3004713352", "1643817", "3018077422", "1417592", "3008403546", "3004111573", "1928237", "2029275", "8022032", "3011494917", "3012811961", "9616096", "3006540014", "3008824097", "1055892", "3011545608", "9614277", "1824619", "3031841433", "3036002406", "3018116884", "1527607", "1526711", "1610287", "3017467279", "3011144486", "3042158935", "9680143", "3011532690", "3013960812", "3005391805", "3004361903", "3010878085", "3011707784", "3008496560", "1054241", "3026197444", "1423537", "3014325891", "9680425", "3003495693", "3007082897", "1420054", "9611594", "3004513970", "3006973666", "3006191977", "3023140882", "3010305275", "3011270181", "3005997949", "3006891803", "3044906632", "3030078769", "1423395", "3006271008", "3006542380", "3045816902", "3019798849", "3014704068", "3045816907", "3009203853", "1000124971", "3013735189", "1055954", "3007344957", "1063382", "3013502418", "2320762", "3005400762", "3015960676", "3004122598", "3014925393", "3004362278", "1923569", "1123010", "2011171", "3011500469", "3043620414", "1721686", "3018071447", "3013466775", "3004519921", "8022210", "3005669815" ], "fei_number": [ "3009637528", "3002669946", "3013298431", "2648727", "3015058854", "3003803331", "3002807170", "3016761372", "3041276890", "3042480961", "3009888344", "3007829657", "3006400329", "3009750712", "3016096096", "3005595283", "3004605321", "2936485", "3015173212", "2433012", "3010376936", "3194", "3000215259", "1000121355", "3007329020", "3002806436", "3002902735", "3002681132", "3005246893", "3017430544", "2024311", "3010166880", "3013421458", "3001236905", "3007289408", "1000117501", "2000028362", "3027977504", "3015895045", "3002806603", "1000512168", "3017636737", "3012595397", "3006450239", "3002807314", "3006846316", "3002805559", "1823410", "1030451", "1047429", "1047843", "3005012805", "3002807308", "3014421917", "3045857302", "3020983482", "3004911384", "1043214", "3007139365", "1000111202", "1018470", "3011554160", "3002692512", "3003924117", "3013600605", "3014680744", "3009773841", "3007007790", "3010452421", "1921846", "3035642068", "3000718854", "3003005156", "3004713352", "1643817", "3018077422", "1417592", "3008403546", "3004111573", "1928237", "3007596547", "3011494917", "3012811961", "3001717360", "3006540014", "3008824097", "3008373372", "3011545608", "1824619", "3031841433", "3036002406", "2523865", "3018116884", "1527607", "3000717925", "1526711", "1610287", "3017467279", "3011144486", "1000112968", "3004829691", "1000306431", "3042158935", "3011532690", "3013960812", "3005846326", "1000123297", "3005391805", "3004361903", "3010878085", "3005596530", "3011707784", "3008496560", "3026197444", "3014325891", "3003495693", "3007082897", "1420054", "3004513970", "3006973666", "3006191977", "3023140882", "3010305275", "3011270181", "3005997949", "3003040625", "3006891803", "1000208624", "3044906632", "3030078769", "3006271008", "1000112877", "3006542380", "3003015552", "3045816902", "3019798849", "3014704068", "3045816907", "3008875470", "3009203853", "1000514656", "1000124971", "3013735189", "3007344957", "3932", "3013502418", "3005400762", "1000160458", "3003807323", "3015960676", "3004122598", "3014925393", "3004362278", "1923569", "1000113384", "2011171", "3011500469", "3043620414", "1721686", "3018071447", "3013466775", "3005669815" ] } } ] }