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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

567

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 961–980 of 7756 recalls

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.

FDAFeb 20, 2024Nationwide• Boston Scientific Corporation

Broncochem Kids Cold & Flu Syrup (Global Corporation) – stability testing failures (2024)

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Class IIModerate

FDAFeb 16, 2024Nationwide• Global Corporation

Broncochem Cold & Tea (Global Corporation) – stability testing failures (2024)

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

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Class IIModerate

FDAFeb 16, 2024Nationwide• Global Corporation

QXDx BCR-ABL Kit (Bio-Rad) – Calibration Inaccuracy (2024)

Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

FDAFeb 15, 2024Nationwide• Bio-Rad Laboratories

Cystatin C Calibrator (Randox) – Bias Concern (2024)

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

FDAFeb 14, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

STERIS Traction Boot (Baxter) – Locking Pin Defect (2024)

Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

FDAFeb 14, 2024Nationwide• Baxter Healthcare Corporation

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).

FDAFeb 12, 2024Nationwide• Boston Scientific Corporation

Bugatti Chiron (Bugatti) – Safety Chime Malfunction (2024)

Bugatti is recalling certain 2016-2023 Bugatti Chiron vehicles. The audible chime may not activate when the vehicle starts, and the driver has not buckled their seat belt. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 208, "Occupant Crash Protection."

NHTSAFeb 9, 2024Nationwide• BUGATTI

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

CLEARLINK Solution Adapter (Baxter) – Potential Leak Risk (2024)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.

FDAFeb 8, 2024Nationwide• Baxter Healthcare Corporation

VERIQA Software (PTW-Freiburg) – Gamma Calculation Issue (2024)

Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results.

FDAFeb 8, 2024GA• PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany

Access Total T4 (Beckman Coulter) – Reagent Imprecision (2024)

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

FDAFeb 8, 2024Nationwide• Beckman Coulter, Inc.

Access Substrate (Beckman Coulter) – Lot Imprecision (2024)

On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.

FDAFeb 7, 2024Nationwide• Beckman Coulter, Inc.

Cerebase DA Guide Sheath (Medos) – Fracture Risk (2024)

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

FDAFeb 2, 2024Nationwide• Medos International Sarl Chemin Blanc 36 Le Locle Switzerland