The Recall Desk

State

Montana product recalls

73,092 recalls have nationwide distribution and so reach Montana. 3,571 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total
3,571
Critical
689
Severe
785
Most recent
2026-09-23

Of the 3,571 recalls naming Montana we have scored against our rubric, 689 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 785 (22%) are Severe.

Which agencies issued them

These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9426–9450 of 76663

  • HighFDA (Devices)·Z-0064-2025·2024-10-23

    Blue Diamond Digital Inflation Devices Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.

    Product
    Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Display Error

    Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2025·2024-10-23

    Olympus EVIS EXERA III Video System Recalled for Startup Failure

    Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.

    Product
    EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2025·2024-10-23

    AVVIGO+ Medical Imaging System Grid Overlay Display Software Error

    Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Overlay Display Error

    A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2025·2024-10-23

    Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects

    Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.

    Product
    Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2025·2024-10-23

    Cryostat Model CM1950 Lacks Warning on Flammable Spray Use

    Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.

    Product
    Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2025·2024-10-23

    Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.

    Product
    basixSKY Inflation Device, REF: SKY1802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2025·2024-10-23

    Cortera spinal fixation system screws recalled due to manufacturing specification concerns

    XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.

    Product
    Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2025·2024-10-23

    Boston Scientific AVVIGO+ Multi-Modality Imaging System Grid Overlay Display Error

    Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error that displays incorrect 9-grid marks instead of 15-grid marks in Live and Record modes. This display error could affect physicians' ability to set proper reference depths during intravascular imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2025·2024-10-23

    Horizon Cardiology Hemodynamic System Recalled for Configuration Error

    Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.

    Product
    Horizon Cardiology Hemo. Version 12.2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0063-2025·2024-10-23

    Stryker 1.2mm Cross Cut Fissure Recalled for Endotoxin Levels

    Stryker is recalling 307 units of 1.2mm Cross Cut Fissure saw blades due to potential endotoxin levels exceeding 2.15 EU/device, which may cause fever, inflammation, or meningitis.

    Product
    1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic appl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0111-2025·2024-10-23

    Boston Scientific AVVIGO+ System Grid Overlay Display Software Error

    Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2025·2024-10-23

    BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk

    BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.

    Product
    BlueFIRE Inflation Device, REF: IN10140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24T012000·2024-10-23

    Michelin Recalls Specialty Tires Missing DOT Certification Markings

    Michelin is recalling certain XVS and TRX specialty tires provided as replacements for a prior recall because they lack the required DOT certification symbol on the sidewalls.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Grid Mark Overlay Defect

    Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software defect that displays an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay when used with OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0102-2025·2024-10-23

    Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error

    Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2025·2024-10-23

    Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error

    Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2025·2024-10-23

    Medline Heart Overhead Table Pack recalled for incorrect model labeling

    Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.

    Product
    MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0033-2025·2024-10-23

    Great Value Cherry Mixed Fruit Recalled for Undeclared Food Colorant

    Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.

    Product
    Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count plastic cups sealed with clear film.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0032-2025·2024-10-23

    Great Value Mixed Fruits Variety Pack Recalled for Undeclared Food Dye

    Walmart is recalling Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack because FD&C Red No. 3 was not declared on the label. The recall affects 511,164 units distributed nationwide.

    Product
    Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 Pack
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0115-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

    Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error

    Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0103-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

    Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay during Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
    Category
    Medical Device
    Distribution
    Distributed nationwide