PlainRecalls

Boston Scientific Corporation

413 recalls on record · Latest: Feb 11, 2026

Boston Scientific Corporation Recall Insight

Boston Scientific Corporation appears on 413 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.492% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Mar 23, 2022 to Nov 29, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 # M005…

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 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 …

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…

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:…

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 urologica…

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 UP…

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 com…

FDA Devices Moderate Mar 15, 2023

LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.

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. Th…

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 i…

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 i…

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 w…

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 w…

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 wit…

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 rad…

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 p…

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

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds