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 Industries identified particulate matter in the fluid path of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. The contamination could potentially affect the safety and performance of these critical medical devices during use.
- Check if your facility has Namic Angiographic Manifolds with Medline Product Number 64038200 and the affected lot numbers listed.
- Do not use affected units. Contact your Medline representative or the FDA for guidance on device replacement or return.
- Review your records to identify any patients who may have been exposed and consult your clinical team as needed.
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
7075 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2026More Medline Industries, LP recalls
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- FDA-Device2026-07-01Medline surgical convenience kits with syringes recalled for unapproved design changes
- FDA-Device2026-07-01Medline medical convenience kits with syringes recalled for unapproved design changes
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