Device recall
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 number
- Z-3297-2026
- Event id
- 99768
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Sep 25, 2026
- Product code
- OHD
- Device type
- Gynecological Laparoscopic Kit
- Reason
- 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
- Under Investigation by firm
- Quantity
- 2957 kits
- Code info
- 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
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States