High risk Medical DevicesClass I

Medline Heart Cath Pack-LF Manifold Recall

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Updated March 24, 2026

Medline has recalled its Heart Cath Pack-LF medical convenience kits (kit number DYNJ36478B) because particulate matter was found inside the fluid path of the included Namic Manifold. Particles in a catheterization manifold's fluid path can enter a patient's bloodstream, posing a serious risk of injury or death.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on March 24, 2026. Details below.

What is recalled

Medline medical convenience kits containing a Namic Manifold, labeled as HEART CATH PACK-LF, Medline Kit Number/SKU: DYNJ36478B. Distributed by Medline Industries, LP.

Am I affected

You are affected if your facility has received or is storing the Medline medical convenience kit labeled HEART CATH PACK-LF with kit number/SKU DYNJ36478B. Check your supply room, procedure trays, or inventory system for that product label and SKU.

What to do right now

Stop using this product immediately. Do not use any kits labeled HEART CATH PACK-LF (SKU DYNJ36478B). Quarantine all affected inventory and contact Medline Industries, LP directly through the FDA recall page (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts) for return and remedy instructions, as no direct consumer contact number was provided in the recall record.

The hazard

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

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2146-2026
Classification
Class I
Recalled
March 24, 2026
Read the official notice

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