{ "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": "2026-10-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Waukegan", "state": "IL", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "99768", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "address_2": "", "postal_code": "60085-8337", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.", "recall_number": "Z-3295-2026", "product_description": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA", "product_quantity": "3677 kits", "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.", "recall_initiation_date": "20260818", "center_classification_date": "20260925", "report_date": "20261007", "code_info": "1) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24309FG2 ; 2) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24352FG2 ; 3) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24317FG2 ; 4) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 25062FG2 ; 5) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25121FG2 ; 6) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25045FG2 ; 7) PGCGLCBAE, UDI-DI: 10198956363366(each), 50198956363364(case), Lot Number: 25217FG2 ; 8) PGCGLCB11, UDI-DI: 10198956116177(each), 50198956116175(case), Lot Number: 24355FG2 ; 9) PV63CMST5, UDI-DI: 10198956526204(each), 50198956526202(case), Lot Number: 25148FG2 ; 10) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 11) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24325FG2 ; 12) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 13) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25029FG2 ; 14) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ; 15) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25045FG2 ; 16) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ; 17) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 18) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25085FG2 ; 19) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: 25217FG2 ; 20) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25217FG2 ; 21) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25216FG2 ; 22) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25274FG2 ; 23) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24325FG2 ; 24) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24309FG2 ; 25) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 26) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24348FG2 ; 27) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 28) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 29) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ; 30) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ; 31) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 32) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 33) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ; 34) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 35) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ; 36) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 37) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 38) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 39) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 40) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 41) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 42) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ; 43) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25069FG2 ; 44) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 45) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25161FG2 ; 46) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 47) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25101FG2 ; 48) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25121FG2 ; 49) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 50) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24353FG2 ; 51) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ; 52) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 53) SLC37LCJ21, UDI-DI: 10198956035850(each), 50198956035858(case), Lot Number: 24317FG2 ; 54) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24317FG2 ; 55) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24348FG2 ; 56) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24353FG2 ; 57) SMA30RBHSA, UDI-DI: 10198956437067(each), 50198956437065(case), Lot Number: 25274FG2", "more_code_info": "" } ] }