← Back to recalls

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

Class I
Recalling firm
Medline Industries, LP
Reason for recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Affected products (lot / model / serial)
UDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.
Units affected
7075 units
Distribution pattern
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-2138-2026
Recall initiated
March 24, 2026
FDA classification date
May 8, 2026
FDA report date
May 20, 2026
FDA event ID
98735
Last updated on HTM Vibe
July 24, 2026
View on openFDA