This is part of a larger recall. The most authoritative record is FDA-Device / Z-3296-2026.

FDA-Device2026-10-07Class IIPROCESSING DEFECT

Cardinal Health Presource surgical kits recalled for fluid leakage risk from tube handpieces

OTHERNationwide distributionMedical devices

What this means

Surgical kits distributed by Cardinal Health contain tube sets with handpieces that may leak fluid during use. Leaking fluid can pool on the floor, creating a slip and fall hazard for operating room staff.

  • Check your inventory for affected Presource Pack kits and matching lot numbers
  • Stop using affected kits immediately
  • Contact Cardinal Health or the FDA with questions about your specific lot numbers
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Affected count
3677 kits
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3295-2026

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