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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2701–2720 of 21320 recalls

EndoVive PEG Kit (Boston Scientific) – Guidewire Blockage (2024)

Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration

High

FDAFeb 20, 2024Nationwide• Boston Scientific Corporation

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Class IIILow

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

1...134 135136137 138...1066

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Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Class IIILow

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

iSLEEVE Introducer Set (Boston Scientific) – Hemostasis Concern (2024)

Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.

High

FDAFeb 20, 2024Nationwide• Boston Scientific Corporation

Abre Venous Stent System (Medtronic) – Package Breach (2024)

There is a potential for sterile package breach.

Moderate

FDAFeb 16, 2024Nationwide• Medtronic Inc.

Origio Sperm Wash Medium (CooperSurgical) – Sodium Pyruvate Risk (2024)

Low concentration of sodium pyruvate in the wash could compromise gamete development

Moderate

FDAFeb 16, 2024Nationwide• CooperSurgical, Inc.

Mariner RDX Head (SeaSpine) – Screw Threading Risk (2024)

Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Moderate

FDAFeb 15, 2024Nationwide• SEASPINE ORTHOPEDICS CORPORATION

DIVA LCD Display (Philips) – Touch Input Malfunction (2024)

If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.

Moderate

FDAFeb 15, 2024Nationwide• Philips North America Llc

Tequesquite (Nicomex) – Elevated Lead (2024)

Elevated lead levels

Class IIILow

FDAFeb 15, 2024IN, NJ, NY• Nicomex Inc.

Fluticasone Nasal Spray (Golden State Medical) – bacterial contamination risk (2024)

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Class IIModerate

FDAFeb 14, 2024Nationwide• Golden State Medical Supply Inc.

Oseltamivir Phosphate Suspension (Amneal) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Out-of-specification test results.

Class IIModerate

FDAFeb 13, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

TMini Knee Instrument (Think Surgical) – Array Guide Issue (2024)

There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

Moderate

FDAFeb 12, 2024Nationwide• Think Surgical, Inc.

POLARSHEATH Steerable Sheath (Boston Scientific) – Manufacturing Defect (2024)

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

Moderate

FDAFeb 12, 2024Nationwide• Boston Scientific Corporation

Clobazam Tablets (Micro Labs) – Residual Solvent Issue (2024)

CGMP Deviations: Out of specification for residual solvents.

Class IIModerate

FDAFeb 12, 2024Nationwide• Micro Labs Limited

Carrier Transicold UG Genset (Carrier) – Equipment Safety Issue (2024)

Fire/Burn Risk

Carrier Corporation (Carrier) is recalling PowerLINE RG15 and UG15 series 24 CARB-compliant generator sets (Models 69RG15-120W-24, 69UG15-050S-24, 69UG15-068S-24, and 69UG15-080S-24). The Diesel Oxidation Catalyst (DOC) may overheat.

High

NHTSAFeb 9, 2024Nationwide• CARRIER TRANSICOLD

Mercaptopurine Tablets (Stason) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Class IIILow

FDAFeb 9, 2024Nationwide• Stason Pharmaceuticals, Inc.

Telmisartan Tablets (Micro Labs) – Blend Uniformity Issue (2024)

Failed Stability Specifications: Out of specification for blend uniformity.

Class IIModerate

FDAFeb 9, 2024RI, TN, PR• Micro Labs Limited

HydrALAZINE Tablets (Harvard Drug) – Impurity Concern (2024)

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Class IIModerate

FDAFeb 9, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Red Velvet Chocolate Bar (Electric City Sweets) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk.

Class IIILow

FDAFeb 9, 2024CA, FL, IN +2 more• Electric City Sweets

Vicinity VI35 (Vicinity) – CNG Tank Contact Risk (2024)

Fire/Burn Risk

Vicinity Motor Corporation (Vicinity) is recalling certain 2022 Vi35 transit buses. Inadequate clearance may allow the CNG tanks to contact the supporting mounting structure and/or safety cables, damaging the tanks.

High

NHTSAFeb 8, 2024Nationwide• VICINITY