← FDA ENFORCEMENT
Z-2140-2026Class I

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Firm state
IL
Product quantity
1975 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Code / lot info

UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256.

Other recalls SPEQ maps to Environmental Monitoring
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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.