FDA (Food) recall action 98194
The FDA (Food) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Undeclared colors FD&C Yellow #5
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Catao Market is recalling 775 master cases of Gaceniga Authentic Cuban Loaf Cake Classic because the colour FD&C Yellow #5 was not declared on the label.
ICU Medical is recalling Plum Duo Precision IV Pumps because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
RaySearch Laboratories is recalling RayStation/RayPlan model 10.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Merit Medical Systems is recalling 2,192 Custom Manifold Kits, REF K09-13203A, because the inflation device handle may detach from the syringe during a procedure.