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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)

145

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 521–540 of 37661 recalls

LGX Preconnect TENACIO Pump (Boston Scientific) – Inflation Problem (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Low

FDASep 11, 2025Nationwide• Boston Scientific Corporation

Freightliner Business Class M2 (Freightliner) – Brake Fastener Risk (2025)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2025 FCCC XCR, FCCC XBS, FCCC MT45, Western Star 57X, 2025-2026 Freightliner Business Class M2, Freightliner Cascadia, Freightliner 114SD, Freightliner 108SD, FCCC MT55G, FCCC MT45G, FCCC XCP, FCCC XCM, Western Star 49X, Western Star 47X, 2026 Freightliner Cascadia 5th Gen, FCCC MT55, and FCCC MT50E vehicles. The brake caliper mounting bolts may loosen and detach, which can cause a loss of brake function and damage the tire and/or wheel.

Moderate

NHTSASep 11, 2025Nationwide• FREIGHTLINER

CXR Preconnect TENACIO Pump (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

1...25 262728 29...1884

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Low

FDASep 11, 2025Nationwide• Boston Scientific Corporation

TENACIO Pump without InhibiZone (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Low

FDASep 11, 2025Nationwide• Boston Scientific Corporation

Olympus Bronchofiberscope BF 1T60 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Moderate

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

ECHELON Linear Cutters (Ethicon) – Unsterilized Devices (2025)

The devices were shipped unsterilized.

Moderate

FDASep 11, 2025Nationwide• Ethicon Endo-Surgery Inc

Olympus Bronchofiberscope BF PE2 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Moderate

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus Bronchovideoscope BF-Q170 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Moderate

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Asiago Texas Toast (Harris Teeter) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.

Class IHigh

FDASep 11, 2025DE, FL, GA +6 more• Harris Teeter

Cinnamon Texas Toast (Harris Teeter) – Undeclared Milk (2025)

Undeclared Allergen

Class IHigh

FDASep 11, 2025DE, FL, GA +6 more• Harris Teeter

iNSitu Bipolar Hip System (Theken) – Sterile Barrier Risk (2025)

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

Moderate

FDASep 11, 2025Nationwide• Theken Companies LLC

Olympus Bronchovideoscope BF-1TH1100 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Moderate

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Der Mutterschaf Cheese (Goot Essa) – Listeria Contamination (2025)

Listeria

The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.

Class IHigh

FDASep 10, 2025CT, MT, NJ +1 more• GOOT ESSA, LLC

Storyteller Overland GXV Hilt (Storyteller) – Wiring Issue (2026)

Fire/Burn Risk

Storyteller Overland, LLC (Storyteller) is recalling certain 2024-2026 GXV Hilt recreational vehicles. The auxiliary power system wires may have been improperly. The wires may be damaged by contact with the intake manifold.

High

NHTSASep 9, 2025Nationwide• STORYTELLER OVERLAND

Ashvins HEYEX 2 (MedicalCommunications) – Measurement Inaccuracy (2025)

Potential that the measured value may be smaller than the actual area.

Moderate

FDASep 9, 2025Nationwide• MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany

CellMek SPS System (Beckman Coulter) – Incorrect Volume Listing (2025)

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

Moderate

FDASep 8, 2025Nationwide• Beckman Coulter, Inc.

C-Rex UNO Goniotomy Instrument (Iantrek) – Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

Low

FDASep 6, 2025Nationwide• Iantrek Inc.

Cyclopen Cyclodialysis System (Iantrek) – Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

Low

FDASep 6, 2025Nationwide• Iantrek Inc.

Spartan Fire Gladiator (Spartan Fire) – Door Latch Actuator (2024)

Fire/Burn Risk

Spartan Fire, LLC (Spartan) is recalling certain 2023-2026 Gladiator, Metrostar, FC-94, KME Panther, and 2024-2025 Predator vehicles. The actuator lever arm in the cab door latch may bind or become wedged, preventing the door from opening.

High

NHTSASep 6, 2025Nationwide• SPARTAN FIRE

Carescape Central Station (Wipro GE Healthcare) – System Failure (2025)

GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

High

FDASep 5, 2025Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India