FDA (Devices) recall action 65083
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Clarification of existing labeling information and operating procedures.
The agency’s own wording, quoted from the enforcement report.
Intuitive Surgical is recalling 8mm cannulas to clarify existing labeling information and operating procedures.
Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.
Intuitive Surgical is recalling da Vinci instrument flush ports to clarify existing labeling and operating procedures.