FDA-Device2026-10-07Class IIPROCESSING DEFECT
Cardinal Health Presource Packs with Stryker tube sets recalled for handpiece fluid leakage risk
What this means
Cardinal Health's Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets may have handpieces that leak fluid during use. Fluid pooling on the floor could create a slip and fall hazard for medical staff.
- Check your inventory for Catalog Number PB63VHSTC, Lot Numbers 25069FG2 or 25101FG2.
- Stop using affected kits immediately.
- Contact Cardinal Health or your supplier for instructions on replacement or return.
- Report any leaks or injuries to your facility's biomedical or safety team.
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
22 kits
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3298-2026More Cardinal Health recalls
- FDA-Device2026-10-07Cardinal Health Presource Packs with Stryker tube sets recalled for handpiece leakage risk
- FDA-Device2026-10-07Cardinal Health Presource surgical kits recalled for fluid leakage risk
- FDA-Device2026-09-30Cardinal Health Presource Convenience Kits recalled for unsealed applicator packaging contamination risk
- FDA-Device2026-09-30Cardinal Health Presource Convenience Kits recalled for potentially contaminated applicators
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.