FDA (Devices) recall action 75055
The FDA (Devices) 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.
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
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.
Ultroid Technologies is recalling 7,784 sterile disposable probes because they were not manufactured under required quality system controls.
Ultroid Technologies is recalling 62 mobile generator units and sterile probes because they were not manufactured under required quality system controls.
The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.
Ultroid Technologies is recalling 52,084 procedure packs because they were not manufactured under required quality system controls.