FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline Namic Angiographic Manifold recalled for particulate contamination in fluid path
OTHERNationwide distribution
Medline Namic Angiographic Manifold recalled for particulate contamination
Medline has identified particles in the fluid pathway of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. These manifolds are used to manage fluid flow during heart and lung bypass surgery. The contamination could potentially affect the safety and performance of the device during use.
- Check if you have a Namic Angiographic Manifold (Medline SKU 64038301) with one of the affected lot numbers listed in the recall notice.
- Do not use affected units; contact Medline or your healthcare facility's medical device coordinator for instructions on device replacement or return.
- If you have questions, contact Medline at the recall hotline provided in the official FDA notice.
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Sold states
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Affected count
38175 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2026More Medline Industries, LP recalls
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline cardiac catheterization manifold kits recalled for particulate contamination
- FDA-Device2026-05-20Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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