FDA-Device2026-10-07Class IIPROCESSING DEFECT
Cardinal Health Presource Packs with Stryker tube sets recalled for handpiece leakage risk
What this means
Surgical kits sold by Cardinal Health that contain Stryker StrykeFlow PS and AHTO tube sets may leak fluid during use. Fluid can pool on the floor, creating a slip and fall hazard for operating room staff.
- Check your surgical kit inventory against the affected catalog numbers and lot numbers listed in the FDA notice
- Stop using affected kits immediately and do not return them to stock
- Contact Cardinal Health or Stryker with your lot numbers for instructions on replacement or return
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
344 kits
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3296-2026Also reported as
More Cardinal Health recalls
- FDA-Device2026-10-07Cardinal Health Presource Packs with Stryker tube sets recalled for handpiece fluid 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
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