Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT

Recalling company

Cardinal Health 200, LLC

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

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 18, 2026

Reported

Oct 7, 2026

Distribution

US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.

Status

Ongoing

Quantity

2957 kits

Lot / codes

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), 50197106

Company location

Waukegan, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-3297-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3297-2026 in the FDA Enforcement Report. Also see FDA recall press releases.