FDA (Devices) recall action 82903
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
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.
Thermo Fisher Scientific is recalling 12 General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to exceed the user's set point.
Thermo Fisher Scientific is recalling 10 Fisher Scientific Isotemp water baths because an assembly error may cause the fluid temperature to rise above the user's set point.
Thermo Fisher Scientific is recalling two Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Thermo Fisher Scientific is recalling four General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Thermo Fisher Scientific is recalling Isotemp 20L General Purpose Water Baths due to assembly errors that may cause the fluid temperature to exceed the user's set point.
Thermo Fisher Scientific is recalling five Isotemp 10L General Purpose Water Baths due to an assembly error that may cause the fluid temperature to rise above the set point.
Thermo Fisher Scientific is recalling four units of the General Purpose Dynamic Bath due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Thermo Fisher Scientific is recalling three General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Thermo Fisher Scientific is recalling four Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the set point.