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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 1181–1200 of 7756 recalls

Guider Softip Guide Catheter 7F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Henke-Ject-2 Syringes (Wolf) – sterile barrier damage (2023)

Sterile barrier might be damaged compromising the sterility of the device.

FDAJul 27, 2023Nationwide• Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany

Peanut Butter Taffy (Mehlenbacher's) – Undeclared Milk (2023)

Undeclared Allergen

Undeclared allergen; milk

Class II

1...58 596061 62...388

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Moderate

FDAJul 20, 2023Nationwide• Mehlenbacher's Taffy

Strawberry Taffy (Mehlenbacher's) – Undeclared Milk (2023)

Undeclared Allergen

Undeclared allergen; milk

Class IIModerate

FDAJul 20, 2023Nationwide• Mehlenbacher's Taffy

Zenition 70 (Philips) – Radiation Exposure Risk (2023)

Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

FDAJul 20, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Watermelon Taffy (Mehlenbacher's) – Undeclared Milk (2023)

Undeclared Allergen

Undeclared allergen; milk

Class IIModerate

FDAJul 20, 2023Nationwide• Mehlenbacher's Taffy

Azurion (Philips) – Unintended Radiation Emission (2023)

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

FDAJul 19, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Allura Xper Series (Philips) – Unintended Radiation Emission (2023)

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

FDAJul 19, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Freedom Boom Models (IHB) – Suspension Arm Weakness (2023)

Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

FDAJul 19, 2023AL, AZ, AR +33 more• IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands

MultiDiagnost-Eleva (Philips) – Unintended Radiation Emission (2023)

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

FDAJul 19, 2023Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Randox Liquid Protein Calibrator (Randox) – Ferritin Restandardization (2023)

As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.

FDAJul 19, 2023CA, FL, IL +6 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification Failure (2023)

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Class IIILow

FDAJul 18, 2023Nationwide• Ascend Laboratories, LLC

RayCare Software (RaySearch) – Allergy Warning Issue (2023)

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

FDAJul 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

L-Aneurysm Clip (Peter Lazic) – Incorrect Color (2023)

Wrong product coloring. The paddle clips should be blank, but they are colored blue.

FDAJul 14, 2023Nationwide• Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany

ACL TOP Family Analyzer (Instrumentation Lab) – Result Misidentification (2023)

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

FDAJul 13, 2023Nationwide• Instrumentation Laboratory

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Uro Kid Support Capsules (Global Vitality) – E. Coli Risk (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Serious Brain Enhancer Capsules (Global Vitality) – E coli contamination (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

FreeStyle Libre 2 Readers (Abbott) – Sensor Start Issue (2023)

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

FDAJul 12, 2023Nationwide• Abbott Diabetes Care, Inc.

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x (Beckman Coulter Inc.) – lipemic interference failed to meet t... (2023)

Lipemic interference failed to meet the performance specification listed within the IFU.

FDAJul 12, 2023AL, AZ, AR +40 more• Beckman Coulter Inc.