FDA (Devices) recall action 79064
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
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.
Ivoclar Vivadent is recalling two units of Heliomolar Refill 20x0.25g 110T because the material was reported to be too soft and sticky, affecting handling.
Ivoclar Vivadent is recalling Heliomolar Refill 20x0.25g 110/A1 because complaints reported the material was too soft and sticky, causing unexpected handling during use.
Ivoclar Vivadent is recalling Heliomolar Refill units because the material was reported to be too soft and sticky, causing handling difficulties.
Ivoclar Vivadent is recalling Heliomolar Refill units because complaints reported the material was too soft and sticky, causing unexpected handling difficulties.