Recall Z-2140-2026— Medline Industries, LP

Name: FDA recall Z-2140-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-24

Class I · Ongoing

Class I FDA medical device recall by Medline Industries, LP, initiated 2026-03-24. It names one FDA 510(k) clearance: K782095. Product: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds..

Recalling firm: Medline Industries, LP
Classification: Class I
Status: Ongoing
Initiated: 2026-03-24
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K782095 — STOPCOCKS, MANIFOLDSNamic·cleared 1979-01-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.