Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIOngoing
Summary: Cardinal Health 200, LLC is recalling 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 , . 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.
What is being recalled
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
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. (states named: California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio, Texas)
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3297-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 18, 2026 |
| Reported | October 7, 2026 |
| Company | Cardinal Health 200, LLC |
| Company location | Waukegan, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2957 kits |
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