# FDA recall Z-2296-2026

> **Bayer Medical Care, Inc.** · Class II · device recall initiated 2026-04-24.

## Product

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System;  Catalog number: AVA 500 MPAT (Part 2 of 2);  Affected material numbers: 87629007, 60729458, 86566648;

## Reason for recall

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.

## Key facts

- **Recall number:** Z-2296-2026
- **Recalling firm:** Bayer Medical Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-24
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianola, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2296-2026

## Citation

> MORVS. FDA recall Z-2296-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2296-2026. Source: US FDA. Licensed CC0.

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