Boston Scientific recalls

Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components
  FDA Device · Class II · 2022-08-10 · Boston Scientific
• GreenLight HPSEA Laser Fibers, UPN 0010-2092
  FDA Device · Class III · 2022-07-27 · Boston Scientific
• EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for u…
  FDA Device · Class II · 2022-05-25 · Boston Scientific
• EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for u…
  FDA Device · Class II · 2022-05-25 · Boston Scientific
• EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for u…
  FDA Device · Class II · 2022-05-25 · Boston Scientific
• EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for…
  FDA Device · Class II · 2022-05-25 · Boston Scientific
• SpaceOAR Vue System, UPN SV-1010 and SV-2101
  FDA Device · Class II · 2022-05-04 · Boston Scientific
• SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101
  FDA Device · Class II · 2022-05-04 · Boston Scientific
• ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
  FDA Device · Class II · 2022-04-20 · Boston Scientific
• ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
  FDA Device · Class II · 2022-04-20 · Boston Scientific
• HYDRATOME RX 44-30MM/260CM Material Number: M00583050
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 44-20-260-035 Material Number: M00573040
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• HYDRATOME RX 49-30MM/260CM Material Number: M00583010
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• HYDRATOME RX 44-30MM/450CM Material Number: M00583070
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 39-20-450-025 Material Number: M00573090
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• DREAMTOME 44-30MM/260CM Material Number: M00584050
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• DREAMTOME 49-20MM/260CM Material Number: M00584000
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• HYDRATOME RX 44-20MM/260CM Material Number: M00583040
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 44-30-260-035 Material Number: M00573060
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 49-30-260-035 Material Number: M00573020
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• DREAMTOME 49-20MM/450CM Material Number: M00584020
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 49-30-450-035 Material Number: M00573030
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 39-30-260-025 Material Number: M00573100
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 39-20-260-025 Material Number: M00573080
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 44-20-450-035 Material Number: M00573050
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 44-30-450-035 Material Number: M00573070
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• HYDRATOME RX 49-20MM/260CM Material Number: M00583000
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 49-20-260-035 Material Number: M00573000
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• DREAMTOME 49-30MM/450CM Material Number: M00584030
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• DREAMTOME 49-30MM/260CM Material Number: M00584010
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• HYDRATOME RX 44-20MM/450CM Material Number: M00583060
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 39-30-450-025 Material Number: M00573110
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• DREAMTOME 44-30MM/450CM Material Number: M00584070
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• JAGTOME RX 39-30-260-025 Material Number: M00573100
  FDA Device · Class II · 2022-03-23 · Boston Scientific
• Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU)
  FDA Device · Class II · 2021-12-22 · Boston Scientific
• HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific
• HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
  FDA Device · Class II · 2021-12-08 · Boston Scientific