FDA (Devices) recall action 94395
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.
Devices may contain elevated levels of bacterial endotoxin.
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.
Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.
Cook Medical is recalling EchoTip Ultra endoscopic ultrasound access needles that may contain elevated bacterial endotoxin levels. The affected units were distributed internationally.