FDA (Devices) recall action 75665
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.
DeRoyal received complaints of mold on Tennis Elbow Straps.
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.
DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.
DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.