FDA (Devices) recall action 92114
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Optical Trocars sterility assurance can not be guaranteed
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.
Surgical Innovations Ltd is recalling 2380 YelloPort Elite optical trocars due to inability to guarantee sterility. Patients using contaminated surgical instruments may develop serious infections.
YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.