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.
RaySearch Laboratories is recalling RayStation/RayPlan model 10.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.
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.
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.
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.