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FDAFDA · Food and drugs·Recall number Z-3296-2026

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI , Catalog Number: PGVMDVB26; 4) KIT,GU DAVINCI , Catalog Number: PGVMDVB27; 5) KIT,GU DAVINCI , Catalog Number: PGVMDVB28; 6) KIT,GU DAVINCI , Catalog Number: PGVMDVB29; 7) COLORECTAL PACK , Catalog Number: SBA73CLKFD; 8) COLORECTAL PACK , Catalog Number: SBA73CLK26

Published October 7, 2026 · Recall initiated: August 18, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Cardinal Health 200, LLC
Distributor
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Lot
1) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2 ; 2) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24353FG2 ; 3) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2 ; 4) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2 ; 5) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25045FG2 ; 6) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2 ; 7) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 24353FG2 ; 8) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25101FG2 ; 9) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25148FG2 ; 10) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25217FG2 ; 11) PGVMDVB26, UDI-DI: 10198956007796(each), 50198956007794(case), Lot Number: 24309FG2 ; 12) PGVMDVB27, UDI-DI: 10198956054714(each), 50198956054712(case), Lot Number: 24325FG2 ; 13) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24317FG2 ; 14) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24325FG2 ; 15) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24317FG2 ; 16) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24348FG2 ; 17) SBA73CLKFD, UDI-DI: 10197106633960(each), 50197106633968(case), Lot Number: 25055FG2 ; 18) SBA73CLK26, UDI-DI: 10198956029828(each), 50198956029826(case), Lot Number: 24309FG2
Risk classification
Class II
Area (FDA)
device
Country
United States

Related recalls

Questions about this recall

Was Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI , Catalog Number: PGVMDVB26; 4) KIT,GU DAVINCI , Catalog Number: PGVMDVB27; 5) KIT,GU DAVINCI , Catalog Number: PGVMDVB28; 6) KIT,GU DAVINCI , Catalog Number: PGVMDVB29; 7) COLORECTAL PACK , Catalog Number: SBA73CLKFD; 8) COLORECTAL PACK , Catalog Number: SBA73CLK26 recalled?

Yes. FDA published recall Z-3296-2026 on October 7, 2026. Reported 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.

What should I do if I have this product?

Voluntary: Firm initiated · Letter

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