FDA (Devices) recall action 98139
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Inflation device handle may detach from the syringe during procedure.
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.
White Castle System is recalling 1,021 cases of White Castle Original Sliders over undeclared milk and soy.
Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.
Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.
Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.
Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.