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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

566

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 1201–1220 of 7756 recalls

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Imp... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

FDAJul 11, 2023Nationwide• Boston Scientific Corporation

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

FDAJul 11, 2023Nationwide• Boston Scientific Corporation

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class II

1...59 606162 63...388

Page 61 of 388Next

Moderate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Big J Unbleached Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Golden Loaf Bakers Flour (Big J Mill) – Potential filth (2023)

Flour may have filth.

Class IIILow

FDAJul 11, 2023IN, UT• Big J Mill & Elevator Company, Incorporated

Succinylcholine Chloride Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Rocuronium Bromide Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Vancomycin IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Phenylephrine HCl IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

Access Thyroglobulin Calibrators (Beckman Coulter, Inc.) – it has been determined through an int... (2023)

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

FDAJul 6, 2023Nationwide• Beckman Coulter, Inc.

woom ORIGINAL Bicycles (woom Bikes) – Fall risk (2023)

This recall involves all sizes of woom ORIGINAL 2018 - 2021 model bikes. The stems on these bikes have one silver bolt to clamp onto the steerer tube. These bikes are designed for children between 18 months and 14 years. They were sold in six versions: woom 1, woom 1 Plus, woom 2, woom 3, woom 4, woom 5 and woom 6. The woom 1 and woom 1 PLUS are balance bikes, woom 2 through 6 are pedal bikes. These bikes were sold in red, green, blue, purple and yellow colors. The word "woom" in white letters is displayed on the sides of the downtube. The word "woom" in metallic letters is also visible on the front of the headtube. The markings "#woombikes" in black letters on chain stay and wheel size in black on sides of the front fork.

CPSCJul 6, 2023Nationwide• woom Bikes USA, of Austin, Texas