PlainRecalls

Boston Scientific Corporation

Compiled from official public sources by the publisher.

632 recalls on record · Latest: Aug 12, 2026

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Agency notice ledger

Federal filing book Boston Scientific Corporati… HEAVY-BOOK · SINGLE-AGENCY

#10 of 14,151 · 632 notices · 0.605% archive

  • BOOK 632 notices
  • RANK #10 of 14,151
  • SHARE 0.605% archive
  • AGENCY FDA Devices (632)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO Garden Fresh Foods, I…

Nearest notice-volume peer: Garden Fresh Foods, Inc. (2 notice gap)

Boston Scientific Corporation sits #10 of 14,151 (10th among 14,151 firms) with 632 federal notices — about 0.605% of the archive (heavy-book tercile). Rank counts issuance frequency, not danger. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Boston Scientific Corporati… sits among 14,151 recalling firms

Boston Scientific Corporation ranks 10th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Boston Scientific Corporati… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

632 10th of 14151 higher than 14,141 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Boston Scientific Corporati… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Boston Scientific Corporation carries 632 distinct federal notices, ranked #10 of 14,151 (heavy-book).

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate May 25, 2022

EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
FDA Devices Moderate May 25, 2022

EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
FDA Devices Moderate May 4, 2022

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
FDA Devices Moderate May 4, 2022

SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
FDA Devices Moderate Apr 20, 2022

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
FDA Devices Moderate Apr 20, 2022

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-20MM/450CM Material Number: M00583060
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-20-260-035 Material Number: M00573040
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 49-20MM/260CM Material Number: M00583000
FDA Devices Moderate Mar 23, 2022

DREAMTOME 44-30MM/260CM Material Number: M00584050
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-20-450-025 Material Number: M00573090
FDA Devices Moderate Mar 23, 2022

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-20MM/260CM Material Number: M00584000
FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-30MM/450CM Material Number: M00584030
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 49-20-260-035 Material Number: M00573000
FDA Devices Moderate Mar 23, 2022

DREAMTOME 44-30MM/450CM Material Number: M00584070
FDA Devices Moderate Mar 23, 2022

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
FDA Devices Moderate Mar 23, 2022

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-20MM/260CM Material Number: M00583040
FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-30MM/260CM Material Number: M00584010
FDA Devices Moderate Mar 23, 2022

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 49-30MM/260CM Material Number: M00583010
FDA Devices Moderate Mar 23, 2022

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-30-260-035 Material Number: M00573060
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-30-450-025 Material Number: M00573110
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-30-450-035 Material Number: M00573070
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-20-450-035 Material Number: M00573050
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-30MM/450CM Material Number: M00583070
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 39-20-260-025 Material Number: M00573080
FDA Devices Moderate Mar 23, 2022

JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
FDA Devices Moderate Mar 23, 2022

DREAMTOME 49-20MM/450CM Material Number: M00584020
FDA Devices Moderate Mar 23, 2022

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 49-30-450-035 Material Number: M00573030
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 49-30-260-035 Material Number: M00573020
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-30MM/260CM Material Number: M00583050
FDA Devices Moderate Dec 22, 2021

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
FDA Devices Moderate Dec 8, 2021

HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
FDA Devices Moderate Aug 25, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
FDA Devices Moderate Aug 25, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA Devices Critical Jul 21, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Devices Critical Jul 21, 2021

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

Boston Scientific Corporati… sits in the heavy federal notice book

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (632 here — heavy-book).

Garden Fresh Foods, Inc. 634 Icu Medical, Inc. 657 Newly Weds Foods, Inc. 657 Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Icu Medical, Inc. 657 Siemens Healthcare Diagnostics, Inc. 665 Customed, Inc 682 Medline Industries, LP 486

Frequently Asked Questions

How many federal recall notices name Boston Scientific Corporati…? ▼
PlainRecalls indexes 632 distinct federal recall events naming Boston Scientific Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Boston Scientific Corporati… sit among other recalling firms? ▼
Boston Scientific Corporation ranks #10 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Boston Scientific Corporati…'s notices? ▼
FDA Devices accounts for 632 of this firm's 632 indexed notices.
What product category dominates Boston Scientific Corporati…'s filing book? ▼
Filings for Boston Scientific Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Boston Scientific Corporation: 632 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Boston Scientific Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026