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Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT… recallZ-2296-2026 · Bayer Medical Care, Inc. · initiated Apr 24, 2026

Class II Open, Classified All recalls posted in June 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bayer Medical Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On April 24, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Customers were instructed to immediately halt the use of the affected product and review inventory for impacted product and quarantine. A Return Goods Authorization will be sent to return any remaining affected inventory. Place the affected product in a box and label the outside of the container with the RGA number provided and RECALL ID: SA-2026-RAD-03 in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return the affected product as soon as possible. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.

Recall details

Recall number
Z-2296-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 24, 2026
Posted by the FDA
Jun 3, 2026
Recalling firm
Bayer Medical Care, Inc.
Quantity
11,300 units (1650 US, 9650 OUS)
Product code
DXT
FDA submissions
K050456
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.

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;

Code information (models, lots, serial numbers)

Catalog number: AVA 500 MPAT (Part 2 of 2) Affected material numbers: 87629007, 60729458, 86566648; Affected batch numbers: 251702, 252302, 252502, 252602, 252702, 252802, 253304, 253702, 253704, 253804, 254202, 254304, 254704, 254802;

Other devices under the same FDA submission

3 devices cleared under K050456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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