# Class II recall Z-3225-2026: Fresenius Medical Care Renal Therapies Group, LLC

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

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3225-2026 |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors;  Model Number: 03-2522-1; |
| Reason | Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. |
| Quantity | 1743026 units |
| Distribution | Domestic: Nationwide Distribution; |
| Recall initiated | 2026-07-29 |
| Reported | 2026-09-30 |
| Firm location | Waltham, MA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 36 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-3225-2026%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.