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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 261–280 of 7756 recalls

ICEfx Maintenance Kit (Boston Scientific) – Desiccant Tube Issue (2025)

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

FDAAug 18, 2025Nationwide• Boston Scientific Corporation

ICEfx Cryoablation System (Boston Scientific) – Desiccant Tube Problem (2025)

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

FDAAug 18, 2025Nationwide• Boston Scientific Corporation

BeneVision N1 Patient Monitor (Mindray) – Alarm Pause Risk (2025)

Potential for activation of an abnormal alarm pause.

FDAAug 15, 2025Nationwide

1...12 131415 16...388

Page 14 of 388Next

• Mindray DS USA, Inc. dba Mindray North America

Raw Frozen Shrimp (Beaver Street Fisheries) – cesium contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137)

Class IIModerate

FDAAug 15, 2025AR, FL, IL• Beaver Street Fisheries, Inc.

Breaded Shrimp (AquaStar) – Cesium-137 contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137).

Class IIModerate

FDAAug 14, 2025AL, AK, AR +27 more• Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

Kroger Cooked Shrimp (AquaStar) – Cesium-137 contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137).

Class IIModerate

FDAAug 14, 2025AL, AK, AR +27 more• Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

AquaStar Cocktail Shrimp (Admiralty Island) – Cesium-137 contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137).

Class IIModerate

FDAAug 14, 2025AL, AK, AR +27 more• Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.

UniCel DxH 690T Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

UniCel DxH 900 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

UniCel DxH 600 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

UniCel DxH 800 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

Everything Bagel Mix (Bakers Authority) – undeclared allergens (2025)

Undeclared Allergen

Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea salt

Class IIModerate

FDAAug 12, 2025CA, CT, GA +14 more• Bakers Authority LLC

Three Seed Mix (Bakers Authority) – undeclared allergens (2025)

Undeclared Allergen

Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flax

Class IIModerate

FDAAug 12, 2025CA, CT, GA +14 more• Bakers Authority LLC

Graham Cracker Meal (Bakers Authority) – Undeclared allergens (2025)

Undeclared Allergen

Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar

Class IIModerate

FDAAug 12, 2025CA, CT, GA +14 more• Bakers Authority LLC

RayStation Software (RaySearch) – UID uniqueness (2025)

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

FDAAug 8, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Argus PB-3000 Monitor (Schiller) – measurement error (2025)

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

FDAAug 8, 2025Nationwide• Schiller, Ag Altgasse 68 Baar Switzerland

Continu-Flo Solution Set (Baxter) – customer reports (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

FDAAug 8, 2025Nationwide• Baxter Healthcare Corporation

IntelliSpace Cardiovascular (Philips) – outdated info (2025)

Software issue that results in the display of outdated information.

FDAAug 8, 2025Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Class IIModerate

FDAAug 8, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Frozen Oysters (Wang Globalnet) – Norovirus contamination (2025)

Oyster product potentially contaminated with Norovirus

Class IIModerate

FDAAug 7, 2025CA, CO, MA +3 more• Wang Globalnet