Medtronic Perfusion Systems: Medical Device Recall in 2025 - (Recall #: Z-0487-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

Product Classification:

Class II

Date Initiated: September 12, 2025

Date Posted: November 19, 2025

Recall Number: Z-0487-2026

Event ID: 97702

Reason for Recall:

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

Status: Ongoing

Product Quantity: 26 units

Code Information:

Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846

Distribution Pattern:

US States: AZ, CA, TN

Voluntary or Mandated:

Voluntary: Firm initiated