# FDA recall Z-3225-2026

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2026-07-29.

## Product

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors;  Model Number: 03-2522-1;

## Reason for recall

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

## Distribution

Domestic: Nationwide Distribution;

## Key facts

- **Recall number:** Z-3225-2026
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-29
- **Report date:** 2026-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3225-2026

## Citation

> MORVS. FDA recall Z-3225-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-3225-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*