{ "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": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "222438", "product_res_number": "Z-3295-2026", "event_date_initiated": "2026-08-18", "event_date_posted": "2026-09-25", "recall_status": "Open, Classified", "res_event_number": "99768", "product_code": "LRO", "product_description": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:\r\n1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; \r\n2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; \r\n3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; \r\n4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; \r\n5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; \r\n6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; \r\n7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; \r\n8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; \r\n9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; \r\n10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; \r\n11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; \r\n12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA", "code_info": "1) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24309FG2 ;\n2) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24352FG2 ;\n3) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24317FG2 ;\n4) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 25062FG2 ;\n5) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25121FG2 ;\n6) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25045FG2 ;\n7) PGCGLCBAE, UDI-DI: 10198956363366(each), 50198956363364(case), Lot Number: 25217FG2 ;\n8) PGCGLCB11, UDI-DI: 10198956116177(each), 50198956116175(case), Lot Number: 24355FG2 ;\n9) PV63CMST5, UDI-DI: 10198956526204(each), 50198956526202(case), Lot Number: 25148FG2 ;\n10) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ;\n11) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24325FG2 ;\n12) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ;\n13) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25029FG2 ;\n14) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ;\n15) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25045FG2 ;\n16) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ;\n17) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ;\n18) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25085FG2 ;\n19) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: 25217FG2 ;\n20) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25217FG2 ;\n21) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25216FG2 ;\n22) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25274FG2 ;\n23) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24325FG2 ;\n24) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24309FG2 ;\n25) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ;\n26) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24348FG2 ;\n27) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ;\n28) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ;\n29) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ;\n30) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ;\n31) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ;\n32) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ;\n33) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ;\n34) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ;\n35) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ;\n36) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ;\n37) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ;\n38) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ;\n39) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ;\n40) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ;\n41) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ;\n42) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ;\n43) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25069FG2 ;\n44) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ;\n45) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25161FG2 ;\n46) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ;\n47) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25101FG2 ;\n48) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25121FG2 ;\n49) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ;\n50) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24353FG2 ;\n51) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ;\n52) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ;\n53) SLC37LCJ21, UDI-DI: 10198956035850(each), 50198956035858(case), Lot Number: 24317FG2 ;\n54) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24317FG2 ;\n55) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24348FG2 ;\n56) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24353FG2 ;\n57) SMA30RBHSA, UDI-DI: 10198956437067(each), 50198956437065(case), Lot Number: 25274FG2", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "Cardinal Health Quality Systems\n800-292-9332", "reason_for_recall": "The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT: PRODUCT CORRECTION notification letter dated 8/18/26 was sent to customers.\n\nPresource has completed its investigation regarding this recall and determined that you may have received Presource kits containing the affected Stryker component(s) and lot number(s). Please reference the attached report identifying your facility s kits, along with the corresponding lot numbers\nthat are affected by this action.\nIf you locate affected product within your facility, please do the following:\n1. QUARANTINE affected kits.\n2. ALERT your clinicians of this action.\n3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to\nclinicians, instructing them to remove and discard the recalled component(s).\n4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this\naction and the completion of labeling product via fax to 614.652.9648.\nAdditional labels will be sent to your facility upon request. Please send an email to:\ngmb-FieldCorrectiveAction@cardinalhealth.com\n\nYour response to this recall notice is required\nPlease fax this form to 614-652-9648 or email to GMB-fieldcorrectiveaction@cardinalhealth.com to acknowledge your receipt of the recall. Please respond even if you do not have recalled product on hand.", "product_quantity": "3677 kits", "distribution_pattern": "US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.", "openfda": { "k_number": [ "K854095", "K926269", "K854292", "K962826", "K941846", "K945160", "K963721", "K030721", "K890570", "K935483", "K895202", "K903336", "K894685", "K932221", "K902887", "K980137", "K871873", "K935740", "K925467", "K884093", "K951149", "K023276", "K970187", "K871322", "K901856", "K871434", "K890098", "K905459", "K885090", "K951478", "K902888", "K871437", "K041080", "K905004", "K932220", "K935743", "K910365", "K935686", "K892389", "K925016", "K945831", "K944044", "K963715", "K934030", "K913136", "K925214", "K952539", "K933137", "K880961", "K873973", "K914037", "K945481", "K950295", "K920292", "K953083", "K872011", "K874439", "K922648", "K930700", "K914036", "K872448", "K932652", "K893814", "K930270", "K931844", "K910368", "K213481", "K932217", "K931673", "K961683", "K936117", "K922133", "K934029", "K212258", "K882684", "K925216", "K965201", "K934028", "K931824", "K963443", "K890729", "K890726", "K961863", "K934428", "K924468", "K935858", "K934688", "K874760", "K890658", "K883250", "K880942", "K931759", "K920267", "K881083", "K935741", "K914174", "K914935", "K970286", "K902293", "K931760", "K842648", "K964921", "K871459", "K971061", "K931820", "K923600", "K931758", "K971062", "K950574", "K964011" ], "registration_number": [ "1417592", "3004361903", "1526711", "2431166", "3014704068", "3005997949", "2029275", "3004111573", "3017430544", "3011494917", "3005669815", "3019798849", "1423395", "3006846316", "3004122598", "3020983482", "1000124971", "1055892", "2024980", "3004513970", "3018116884", "2000028362", "3042480961", "3007344957", "3005400762", "3006891803", "1643817", "3005246893", "1527607", "3004605321", "1063382", "1644019", "2936485", "3023140882", "3005012805", "3006973666", "3013466775", "3007139365", "1650907", "1824619", "3007289408", "3007829657", "9680357", "3014325891", "3006450239", "3004713352", "3010166880", "9681709", "3041276890", "3031841433", "1424263", "3004519921", "3015960676", "3009203853", "1610287", "3009750712", "9611594", "9616088", "3005391805", "3010305275", "3007007790", "3013502418", "3030078769", "3008496560", "2320762", "1061124", "9680143", "3013735189", "3009773841", "3011270181", "1420054", "2648727", "3006191977", "1055236", "3002669946", "3035642068", "3010452421", "3017467279", "1060680", "3004911384", "8030672", "3012811961", "3013421458", "8022210", "3010376936", "3011554160", "3011500469", "1047843", "3012595397", "3006400329", "1047429", "3016096096", "1123010", "1423537", "3007082897", "1923569", "2011171", "3009637528", "3002806603", "3042158935", "1928237", "3014680744", "3015173212", "3005595283", "3016761372", "3006540014", "1065597", "3027977504", "3015895045", "1823410", "9616096", "3008403546", "9614277", "8030678", "8022032", "3043620414", "1018470", "3009888344", "3026197444", "3045816902", "3044906632", "1055954", "3006673317", "3006271008", "1422634", "1066741", "3014421917", "2024311", "3018077422", "3011545608", "9680425", "1043214", "3014925393", "3002807314", "3036002406", "1030451", "3045857302", "3008824097", "1121203", "1721686", "2029015", "3011532690", "3010878085", "3003924117", "3015058854", "3018071447", "3007329020", "3003495693", "3006542380", "3004362278", "3013600605", "3013960812", "3011707784", "3013298431", "3045816907", "3014718111", "1921846", "1054241", "3011144486", "9611024", "3017636737", "2433012" ], "fei_number": [ "1417592", "3004361903", "3003803331", "3002692512", "1526711", "1000121355", "3014704068", "1000514656", "3005997949", "3017430544", "3004111573", "3019798849", "3011494917", "3005669815", "3006846316", "3008875470", "3004122598", "3020983482", "1000124971", "3004513970", "3018116884", "2000028362", "3042480961", "3007344957", "3005400762", "3006891803", "1643817", "1000123297", "3005246893", "1527607", "3004605321", "2936485", "3023140882", "3003807323", "3005012805", "3006973666", "1000112877", "3013466775", "3007139365", "1000160458", "3000718854", "1824619", "3007289408", "3007829657", "3014325891", "1000512168", "1000117501", "3006450239", "3004713352", "3005846326", "3010166880", "3041276890", "3031841433", "3015960676", "3009203853", "1610287", "3009750712", "3003015552", "3007596547", "3005391805", "3010305275", "3007007790", "3013502418", "3030078769", "3008496560", "3001717360", "3013735189", "3009773841", "3011270181", "1420054", "2648727", "3006191977", "3003005156", "3002669946", "1000111202", "3035642068", "3010452421", "3005596530", "3017467279", "3004911384", "3012811961", "3013421458", "3003040625", "3010376936", "3011554160", "3011500469", "1047843", "3012595397", "3006400329", "3932", "1047429", "3016096096", "3002807308", "3007082897", "3002806436", "1923569", "2011171", "3009637528", "3002806603", "3042158935", "1928237", "3014680744", "3015173212", "3005595283", "3016761372", "2523865", "3006540014", "3002805559", "3027977504", "3015895045", "1823410", "3004829691", "3008403546", "3043620414", "3001236905", "1018470", "3194", "3009888344", "3026197444", "3045816902", "1000112968", "3044906632", "1000306431", "3006271008", "3002902735", "3002681132", "3014421917", "2024311", "3018077422", "3011545608", "1043214", "1000208624", "1000113384", "3014925393", "3002807314", "3036002406", "1030451", "3000717925", "3045857302", "3008824097", "1721686", "3008373372", "3011532690", "3010878085", "3003924117", "3015058854", "3018071447", "3007329020", "3003495693", "3006542380", "3004362278", "3013600605", "3013960812", "3011707784", "3013298431", "3045816907", "1921846", "3011144486", "3000215259", "3017636737", "3002807170", "2433012" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }