OVERLOOKED

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Class IIOngoing

Cardinal Health 200, LLC recalls 4 products

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Cardinal Health 200, LLC
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99768…

Products (4)

  1. Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA

    Codes/lots: 1) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24309FG2 ; 2) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24352FG2 ; 3) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24317FG2 ; 4) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 25062FG2 ; 5) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25121FG2 ; 6) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25045FG2 ; 7) PGCGLCBAE, UDI-DI: 10198956363366(each), 50198956363364(case), Quantity: 3677 kitsRecall no. Z-3295-2026Class II

  2. 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

    Codes/lots: 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), Quantity: 344 kitsRecall no. Z-3296-2026Class II

  3. 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

    Codes/lots: 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(Quantity: 2957 kitsRecall no. Z-3297-2026Class II

  4. Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC

    Codes/lots: 1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2Quantity: 22 kitsRecall no. Z-3298-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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