Boston Scientific Corporation
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.
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…
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…
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…
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…
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or com…
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage…
ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas,…
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage canc…
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. Th…
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. Th…
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific im…
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
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…
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…
GreenLight HPSEA Laser Fibers, UPN 0010-2092
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wit…
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wi…
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…
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…
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
JAGTOME RX 44-20-260-035 Material Number: M00573040
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
DREAMTOME 44-30MM/260CM Material Number: M00584050
JAGTOME RX 39-30-260-025 Material Number: M00573100
JAGTOME RX 39-20-450-025 Material Number: M00573090
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
DREAMTOME 49-20MM/260CM Material Number: M00584000
DREAMTOME 49-30MM/450CM Material Number: M00584030
JAGTOME RX 49-20-260-035 Material Number: M00573000
DREAMTOME 44-30MM/450CM Material Number: M00584070
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
DREAMTOME 49-30MM/260CM Material Number: M00584010
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
JAGTOME RX 44-30-260-035 Material Number: M00573060
JAGTOME RX 39-30-450-025 Material Number: M00573110
JAGTOME RX 44-30-450-035 Material Number: M00573070
Nearby Manufacturers
Other firms with recall activity tracked in the PlainRecalls index.
Zimmer Biomet, Inc.
View recalls →
MEDLINE INDUSTRIES, LP - Northfield
View recalls →
Siemens Medical Solutions USA, Inc
View recalls →
FORD
View recalls →
Customed, Inc
View recalls →
Compare Boston Scientific Corporation with Zimmer Biomet, Inc. →
Data Sources
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.