Cardinal Health 200, LLC — 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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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.

Provider
FDA — device enforcement reference
Source observed
8/18/2026, 12:00:00 AM UTC
Source updated
9/25/2026, 12:00:00 AM UTC
Location
Waukegan, IL, US
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.
notice
Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product
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
distribution
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
event number
99768
manufacturer
Cardinal Health 200, LLC
recall number
Z-3296-2026
source status
Open, Classified
freshness minutes
180
Read the official source

Source use policy · openFDA reference data; not a real-time public alert service

Update history (1 recent revisions)
  • 10/8/2026, 2:10:42 AM UTC

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