FDA recall Z-2139-2026

Product

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Reason for recall

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Distribution

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

Key facts

Status

Ongoing

Initiation date

2026-03-24

Report date

2026-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2026