Official recall notice

FDA DeviceClass IINotable

Presource Packs Recall (Oct 2026) – Cardinal Health 200

Product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA3; 5) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA4; 6) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLD; 7) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLE; 8) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL5; 9) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL6; 10) MVHS GU GYN ROBOT PACK , Catalog Number: SOTDKGREFB

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

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.

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Product description

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.

Affected products

1) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24317FG2 ; 2) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24347FG2 ; 3) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24355FG2 ; 4) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25069FG2 ; 5) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25014FG2 ; 6) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25029FG2 ; 7) PB23GLNLA1, UDI-DI: 10197106809969(each), 50197106809967(case), Lot Number: 20 ; 8) PB23GLNLA2, UDI-DI: 10198956053328(each), 50198956053326(case), Lot Number: 24317FG2 ; 9) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24309FG2 ; 10) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24317FG2 ; 11) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24325FG2 ; 12) PB23GLNLA4, UDI-DI: 10198956072664(each), 50198956072662(case), Lot Number: 24317FG2 ; 13) PB23GLNLA4, UDI-DI: 10198956072664(each), 50198956072662(case), Lot Number: 24325FG2 ; 14) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2 ; 15) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24355FG2 ; 16) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24317FG2 ; 17) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2 ; 18) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2 ; 19) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25029FG2 ; 20) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25045FG2 ; 21) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24317FG2 ; 22) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25065FG2 ; 23) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25062FG2 ; 24) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25085FG2 ; 25) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25097FG2 ; 26) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25101FG2 ; 27) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25148FG2 ; 28) PB23GRNLE, UDI-DI: 10198956320178(each), 50198956320176(case), Lot Number: 25217FG2 ; 29) PB23GRNL5, UDI-DI: 10198956050419(each), 50198956050417(case), Lot Number: 24325FG2 ; 30) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24299FG2 ; 31) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24317FG2 ; 32) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24325FG2 ; 33) SOTDKGREFB, UDI-DI: 10198956112766(each), 50198956112764(case), Lot Number: 25154FG2

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