Critical Alert
Medline Industries Recalls Namic Angiographic Manifold
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2138-2026Medical Device
Medline Industries Recalls Namic Angiographic Manifold
Medline Industries, LP · Class I — Most Serious
Product Description
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Reason for Recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a medical device recalled by Medline Industries, LP on March 24, 2026. Medline has identified the presence of particulate within the fluid path of the Manifolds. This recall affects 7075 units and was distributed nationwide. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination and Medline Industries recalls.