Boston Scientific Corporation
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
- Customed, Inc
Customed, Inc
682 notices
- Siemens Healt…
Siemens Healthcare Diagnostics, Inc.
665 notices
- Icu Medical,…
Icu Medical, Inc.
657 notices
- Newly Weds Fo…
Newly Weds Foods, Inc.
657 notices
- Garden Fresh…
Garden Fresh Foods, Inc.
634 notices
- Boston Scient… (this)
Boston Scientific Corporation
632 notices
What this shows Boston Scientific Corporation carries 632 distinct federal notices, ranked #10 of 14,151 (heavy-book).
FDA Devices Moderate Apr 3, 2024
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
FDA Devices Critical Apr 3, 2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
FDA Devices Moderate Feb 28, 2024
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
FDA Devices Moderate Jan 17, 2024
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.
FDA Devices Moderate Nov 29, 2023
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
FDA Devices Moderate Nov 29, 2023
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
FDA Devices Moderate Oct 11, 2023
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
FDA Devices Moderate Aug 30, 2023
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
FDA Devices Moderate Aug 30, 2023
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
FDA Devices Moderate Aug 2, 2023
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
FDA Devices Moderate May 24, 2023
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
FDA Devices Moderate May 24, 2023
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
FDA Devices Moderate Apr 26, 2023
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070
FDA Devices Moderate Mar 15, 2023
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
FDA Devices Moderate Nov 16, 2022
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1 M00519200 (2)Twin Pack Box 10 M00519201 (3)Single Pack Box
FDA Devices Moderate Nov 16, 2022
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231
FDA Devices Moderate Nov 16, 2022
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390;
FDA Devices Moderate Nov 9, 2022
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
FDA Devices Moderate Nov 9, 2022
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
FDA Devices Moderate Nov 9, 2022
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
FDA Devices Moderate Sep 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Devices Moderate Sep 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Devices Moderate Sep 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Devices Moderate Aug 31, 2022
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA Devices Moderate Aug 10, 2022
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
FDA Devices Moderate Aug 10, 2022
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
FDA Devices Low Jul 27, 2022
GreenLight HPSEA Laser Fibers, UPN 0010-2092
FDA Devices Moderate May 25, 2022
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 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 1) UPN: M00542420 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.
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).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
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