FDA (Devices) recall action 61879
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.
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
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.
Varian Medical Systems is recalling stainless steel rectal retractors used in brachytherapy due to potential contamination that could cause infections, toxicity, or allergic reactions.
Varian Medical Systems is recalling 152 titanium rectal retractors used in brachytherapy due to potential contamination risks that could cause infections, toxicity, or allergic reactions.