Recall Z-2296-2026— Bayer Medical Care, Inc.

Name: FDA recall Z-2296-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Class II · Ongoing

Class II FDA medical device recall by Bayer Medical Care, Inc., initiated 2026-04-24. It names one FDA 510(k) clearance: K050456. 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: 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..

Recalling firm: Bayer Medical Care, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-24
Firm location: Indianola, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K050456 — MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMMedrad, Inc.·cleared 2005-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.