PlainRecalls

Boston Scientific Corporation

Compiled from official public sources by the editorial team.

605 recalls on record · Latest: May 13, 2026

Boston Scientific Corporation Recall Insight

Boston Scientific Corporation appears on 605 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.595% 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 May 13, 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, 49 moderate, and 1 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 Aug 2, 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 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 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 urologic…

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 urolo…

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 16, 2022

ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage…

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,…

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 canc…

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 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 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 im…

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 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 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 25, 2022

EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wi…

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

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

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Boston Scientific Corporation with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.