FDA (Devices) recall action 89468
The FDA (Devices) publishes a recall like this one as 31 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 31 pages.
Sterility of device is compromised due to a sterile barrier breach
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.
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
Boston Scientific is recalling 68 JAGTOME REVOLUTION RX medical devices due to sterile barrier breach. The devices were distributed worldwide including throughout the US.
Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.
Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.
Boston Scientific is recalling 96 units of JAGTOME RX medical devices due to a sterile barrier breach that compromises device sterility. Patients should contact their physician if they received this device.
Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.