FDAClass I · Medical device · Recalled May 20, 2026

Namic Angiographic Manifold recall — Medline Industries, LP

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

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2139-2026
Brand: Medline Industries
Classification: Class I
Units affected: 38175 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Namic Angiographic Manifold

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: UDI/DI each 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812,
Distribution: US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98735
Recall initiated: March 24, 2026
FDA classified: May 8, 2026
FDA report date: May 20, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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