Boston Scientific recalls
Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult p…
FDA Device · Class II · 2024-04-17 · Boston Scientific - EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients…
FDA Device · Class II · 2024-04-17 · Boston Scientific - Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA Device · Class I · 2024-04-03 · Boston Scientific - OptiCross Coronary Imaging Catheter, REF H749518080120
FDA Device · Class II · 2024-04-03 · Boston Scientific - Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
FDA Device · Class I · 2024-04-03 · Boston Scientific - Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
FDA Device · Class II · 2024-04-03 · Boston Scientific - EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510
FDA Device · Class II · 2024-02-28 · Boston Scientific - Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used…
FDA Device · Class II · 2024-01-17 · Boston Scientific - EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0
FDA Device · Class II · 2023-11-29 · Boston Scientific - EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box…
FDA Device · Class II · 2023-11-29 · Boston Scientific - Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - EMBLEM MRI S-ICD Pulse Generator Model A219
FDA Device · Class II · 2023-08-30 · Boston Scientific - EMBLEM S-ICD Pulse Generator Model A209
FDA Device · Class II · 2023-08-30 · Boston Scientific - Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser co…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser console…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser c…
FDA Device · Class II · 2023-08-02 · Boston Scientific - Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Singl…
FDA Device · Class II · 2023-08-02 · Boston Scientific - 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…
FDA Device · Class II · 2023-08-02 · Boston Scientific - 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 t…
FDA Device · Class II · 2023-08-02 · Boston Scientific - WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
FDA Device · Class II · 2023-05-24 · Boston Scientific - WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
FDA Device · Class II · 2023-05-24 · Boston Scientific - Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm)
FDA Device · Class II · 2023-04-26 · Boston Scientific - LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460
FDA Device · Class II · 2023-03-15 · Boston Scientific - ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early s…
FDA Device · Class II · 2022-11-16 · Boston Scientific - ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, ea…
FDA Device · Class II · 2022-11-16 · Boston Scientific - ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps,…
FDA Device · Class II · 2022-11-16 · Boston Scientific - EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile
FDA Device · Class II · 2022-11-09 · Boston Scientific - EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile
FDA Device · Class II · 2022-11-09 · Boston Scientific - 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 Device · Class II · 2022-11-09 · Boston Scientific - The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse gene…
FDA Device · Class II · 2022-09-07 · Boston Scientific - The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse gene…
FDA Device · Class II · 2022-09-07 · Boston Scientific - The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Sci…
FDA Device · Class II · 2022-09-07 · Boston Scientific - Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA Device · Class II · 2022-08-31 · Boston Scientific - EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components
FDA Device · Class II · 2022-08-10 · Boston Scientific