FDA (Devices) recall action 82894
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.
The seal integrity of the sterile bag containing the kits may be compromised.
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.
Stryker GmbH is recalling 1,600 Endotrac EPF/EGR Hook/Triangle Blade Kits because the sterile bag seal integrity may be compromised.
Stryker GmbH is recalling 447 Endotrac ECTR Hook/Triangle Blade Kits because the sterile bag seal may be compromised, potentially affecting sterility.