Medical device recalls High risk

Medline Industries, LP recalls Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, man…

Recall date
March 24, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2138-2026
FDA classification
Class I
Brand / firm
Medline Industries, LP
Sold / distributed
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

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