Particulate inside the path that reaches the bloodstream — 21,119 kits, Japan among the destinations (Medline)

1A Class I recall of medical kits

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).

2Kits containing Namic manifolds

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.

3Distribution including Japan

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.

4Thirty-nine records cite particulate

Of the 1,408 FDA recall records this site holds as of 2026-09-01, 39 cite particulate as the reason for recall.

Particulate is not always something the eye catches. On a product used outside the body, finding it has limited consequence; found inside the path that carries fluid into a blood vessel, as here, it travels onward into the patient. The same foreign matter is treated differently depending on where it turns up.