Class I (most serious) Medical Device Z-2147-2026 Ongoing

FDA Class I recall: particulate in Medline cardiac-catheter manifolds (Namic) — distribution includes Japan

Medline Industries, LP ・Reported May 20, 2026

Medline recalled medical kits containing Namic manifolds (used in cardiac catheterization / angiography) after identifying particulate within the manifolds' fluid path. The FDA classified it Class I, the most serious. Distribution includes Japan.

Recall overview (primary data)

ClassificationClass I (most serious)
Product typeMedical Device
Recalling firmMedline Industries, LP
ReasonMedline has identified the presence of particulate within the fluid path of the Manifolds.
DistributionUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Recall initiated2026-03-24

Key points

Particulate identified in the fluid path of Namic manifolds used in cardiac-cath / angiography kits
FDA classified it Class I (recall Z-2147-2026, reported May 20, 2026, ongoing)
About 21,119 kits; firm-initiated (recall initiated March 24, 2026)
Distribution includes Japan (plus U.S. nationwide and AE/AU/CA/KR/NL/SG/SK)
Particulate entering the vasculature during procedures raises embolism risk

The U.S. FDA classified Medline Industries' recall of medical kits as Class I — its most serious class (use may cause serious adverse health consequences or death) — recall number Z-2147-2026, reported May 20, 2026, status ongoing (firm-initiated).

The affected products are medical convenience kits containing Namic manifolds (the fluid-path components that switch the injection of contrast/medication and pressure measurement in catheter procedures), including cardiac-cath and angiography packs. Medline identified the presence of particulate within the fluid path of the manifolds. The recall was initiated March 24, 2026, affecting about 21,119 kits.

Distribution spans the U.S. nationwide plus, internationally, Japan, the UAE, Australia, Canada, South Korea, the Netherlands, Singapore, and Slovakia. In catheter procedures, particulate from the fluid path can enter the patient's vasculature, raising the risk of serious harm such as embolism — the basis for the Class I classification.

Why it matters

A Class I device recall whose distribution includes Japan and several other markets. A useful pointer for hospital procurement and patient-safety/risk teams to check whether affected products and lots are in use; confirm specifics with FDA and the manufacturer/distributor.

FAQ

What is a Class I recall?

The FDA's most serious class, used when there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

What is a manifold?

A fluid-path component in catheter procedures that switches contrast, medication, or saline injection and pressure measurement. Here, particulate was found within that fluid path.

Sources (primary)

Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.

#FDA#Recall#Medical device#Class I#Cardiac catheter#Distributed to Japan

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