FDA (Devices) recall action 77637
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.
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
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.
Cenorin, LLC is recalling 18 ThermaSure Series 1000 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.
Cenorin, LLC is recalling 34 ThermaSure Series 130 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.
Cenorin, LLC is recalling 43 ThermaSure Series 300 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.