Class II recall Z-3297-2026: Cardinal Health 200, LLC
Class II recall Z-3297-2026: Cardinal Health 200, LLC (Illinois): Cardinal Health 200, LLC. Dated 28 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3297-2026 |
| 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, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA3; 5) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA4; 6) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLD; 7) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLE; 8) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL5; 9) KIT, GYN R |
| 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 | 2957 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 |
| Peer records CSV (57 IL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-3297-2026: Cardinal Health 200, LLC and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 28 days ago.
What is the FDAPulse record for Class II recall Z-3297-2026: Cardinal Health 200, LLC in Illinois?
Class II device recall Z-3297-2026 by Cardinal Health 200, LLC: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failure
How does Class II recall Z-3297-2026: Cardinal Health 200, LLC compare to other Illinois FDAPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Class II recall Z-3297-2026 vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3297-2026 | IL | 2026-10-07 |
| Class II recall Z-0281-2027 | IL | 2026-10-28 |
| Class II recall Z-0275-2027 | IL | 2026-10-28 |
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