Class IIDeviceOngoing

Cardinal Health 200, LLC

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

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.

Details

Recall number: Z-3295-2026
Event ID: 99768
Recall initiated: Aug 18, 2026
Classified: Sep 25, 2026
Reported: Oct 7, 2026
Quantity: 3677 kits
Distribution: US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waukegan, IL, United States
Lot / 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