# Class II recall Z-3295-2026: Cardinal Health 200, LLC

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3295-2026 |
| 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, 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 PA |
| 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 | 3677 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 29 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-3295-2026%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.