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 Dec 30, 2020
IceSphere" 1.5 CX 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 S 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 PLUS 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
Five IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSeed" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX L 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 MRI Cryoablation Needle¿
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 PLUS Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
FDA Devices Moderate Dec 30, 2020
IceRod" He-Thaw Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceSeed" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceRod" i-Thaw" Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceRod" 1.5 MRI 90¿ Cryoablation Needle¿
FDA Devices Moderate Dec 30, 2020
IcePearl" 2.1 CX Prostate Cryoablation Kit
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿
FDA Devices Moderate Dec 30, 2020
IceSphere" 1.5 90¿ Cryoablation Needle
FDA Devices Moderate Dec 23, 2020
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultras
FDA Devices Moderate Nov 18, 2020
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
FDA Devices Moderate Nov 11, 2020
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
FDA Devices Moderate Nov 4, 2020
Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.
FDA Devices Moderate Nov 4, 2020
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.
FDA Devices Moderate Oct 28, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
FDA Devices Moderate Sep 23, 2020
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loo
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loo
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loo
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loo
FDA Devices Moderate Aug 12, 2020
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loo
FDA Devices Moderate Aug 12, 2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loo
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
FDA Devices Moderate Jul 29, 2020
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
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