This is part of a larger recall. The most authoritative record is FDA-Device / Z-2144-2026.
FDA-Device2026-05-20Class IPROCESSING DEFECT
Medline HEART CATH PACK-LF medical kits recalled for particulate contamination in fluid path
OTHERNationwide distribution
Medline HEART CATH PACK-LF kits recalled for particulate contamination
Medline identified particles inside the fluid pathway of Namic Manifolds used in HEART CATH PACK-LF medical convenience kits. These particles could potentially interfere with the safe operation of the device during cardiac catheterization procedures.
- If you have a HEART CATH PACK-LF kit with Lot Number 26CMC977, stop using it immediately
- Contact Medline or your healthcare facility for instructions on returning or replacing affected kits
- Check your facility's inventory using the UDI/DI numbers 10889942814619 (individual) or 40889942814610 (case)
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
0 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2026More 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 Namic Angiographic Manifold recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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