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 KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.
Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.
Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.
Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.
Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.
Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.
Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.
Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect device sterility.
Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.
Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.
Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. The affected units were distributed worldwide.
Fifteen Boston Scientific DREAMTOME medical devices are being recalled due to a sterile barrier breach that compromises device sterility. The affected lot number 27802363 requires appropriate action.
Boston Scientific is recalling 7,695 units of HYDRATOME RX devices worldwide due to compromised sterility from a sterile barrier breach. Affected devices may pose a risk of infection.
Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects device sterility.
Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.
Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices were distributed worldwide.
Boston Scientific is recalling 7,115 units of JAGTOME REVOLUTION RX devices worldwide due to sterile barrier breach that could allow contamination.
Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.
Boston Scientific has recalled 3,578 units of the JAGTOME RX medical device due to sterility compromise from a barrier breach. Affected units were distributed worldwide.
Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.
Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.
Boston Scientific has recalled 1,447 units of the JAGTOME RX 39-30-260-025 medical device due to a compromised sterile barrier that affects device sterility. The affected devices were distributed worldwide.
Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.
Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
Boston Scientific has recalled 2209 units of the JAGTOME RX medical device worldwide due to compromised sterility from a sterile barrier breach. The affected units were distributed across the US and more than 40 countries.