Manufacturer
639 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.
Of the 639 recalls from Boston Scientific Corporation we have scored against our rubric, 57 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 102 (16%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
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 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 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.
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.
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.
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 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 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 is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.
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 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 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's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
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.
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 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 98 JAGTOME RX medical devices due to a sterile barrier breach. The 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 recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.
Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.
Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.
Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.
Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.
Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Boston Scientific
worldwide developer, manufacturer and marketer of medical devices
Source: Wikidata (Q894585), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.