FDA Medical devices recall ·
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2))… recall
- Recall number
- Z-2296-2026
- Date
- (initiated April 24, 2026)
- Company / brand
- Bayer Medical Care, Inc.
1 Bayer Dr, Indianola, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,300 units (1650 US, 9650 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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;
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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;
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.
States: Alabama Arkansas Arizona California Colorado Delaware Florida Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Missouri Montana North Carolina New York Ohio Oklahoma Pennsylvania South Carolina Tennessee Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2296-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.