FDA (Devices) recall action 82489
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The heated tube sets were consistently leaking and detaching from the cassette.
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 is recalling High Flow II Tube Sets because they consistently leak and detach from the cassette. The product is a medical device accessory distributed nationwide and internationally.
Stryker is recalling High Flow Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
Stryker is recalling 19,083 boxes of Heated Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.