# Class II recall Z-3296-2026: Cardinal Health 200, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3296-2026 |
| Recalling firm | Cardinal Health 200, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 |
| 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. |
| Quantity | 344 kits |
| Distribution | US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. |
| Recall initiated | 2026-08-18 |
| Reported | 2026-10-07 |
| Firm location | Waukegan, IL, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3296-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.