FDA (Devices) recall action 79731
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
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.
Cook Inc. is recalling 470 StoneBreaker Sterilization Caps because the interior may not reach the required Sterility Assurance Level during reprocessing.
Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.
Cook Inc. is recalling 629 StoneBreaker Exhaust Caps because the interior may not be sterilized to the appropriate level when following reprocessing instructions.
Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.
Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.
Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.
Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.