The Recall Desk

Archive

October 2024 recalls

601 recalls were announced in October 2024.

What the numbers show

Critical
4
Severe
86
High
449
Moderate
62

Of the 601 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

Which agencies issued them

201–300 of 601

  • HighFDA (Food)·F-0049-2025·2024-10-23

    Lemonland Wild Leeks Recalled for Undeclared Wheat and Fish Allergens

    Lemonland Food Corp is recalling Item FLD1040A Wild Leeks distributed in Washington due to undeclared wheat and fish (anchovy) allergens. The product label declares soy sauce but omits mandatory allergen warnings.

    Product
    Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, Soy Sauce.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0091-2025·2024-10-23

    Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution

    Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.

    Product
    Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2025·2024-10-23

    Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays

    Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.

    Product
    Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2025·2024-10-23

    Monarch Inflation Devices Recalled for Sterile Barrier Defects

    Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.

    Product
    Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2025·2024-10-23

    Custom Inflation Kits Recalled Due to Sterile Barrier Defect and Infection Risk

    Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.

    Product
    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0034-2025·2024-10-23

    Bevi Flavor#115 Electrolytes Recalled: Mislabeled, Contains Caffeine

    Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.

    Product
    Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single unit for use in Bevi Smart Water Cooler machines dispensing flavored waters.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Recalled for Grid Overlay Display Error

    Boston Scientific is recalling AVVIGO+ systems due to a software anomaly that displays an incorrect grid overlay when connected to OptiCross 18 catheters, potentially leading to vessel imaging misinterpretation.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which inc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0050-2025·2024-10-23

    Stir Fried Dried Shrimp Recalled for Undeclared Wheat Allergen

    Lemonland Food Corp recalled stir-fried dried shrimp (Item FLD1971) distributed in Washington because wheat is not declared on the label, despite being present in the product.

    Product
    Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, Salt
    Category
    Food
    Distribution
    1 state
  • 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-0069-2025·2024-10-23

    MONARCH Inflation Device Recalled Due to Sterile Barrier Defect Risk

    Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to infection.

    Product
    MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
    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-0126-2025·2024-10-23

    Change Healthcare Cardiology Hemodynamic Software Calculation Error Recall

    Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.

    Product
    Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0096-2025·2024-10-23

    Boston Scientific Medical Device Software Error Affects Vessel Imaging Display

    The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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
  • HighFDA (Devices)·Z-0061-2025·2024-10-23

    Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.

    Product
    Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0052-2025·2024-10-23

    Lunds & Byerlys Lone Star Dip Recalled for Potential Mold Contamination

    Lund Food Holdings Inc is recalling Lunds & Byerlys Lone Star Dip (12 oz) due to potential mold contamination. The affected product was distributed in Minnesota.

    Product
    Lunds & Byerlys lone star dip. Net Wt 12 oz. (340.5g) UPC 0 18169-74197 9. Produced by Lunds & Byerlys, Edina, MN 55424.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0047-2025·2024-10-23

    Seasoned Peanut Recalled Due to Undeclared Wheat Allergen

    Lemonland Food Corp recalls Item FLD1010A Seasoned Peanut due to undeclared wheat on the label. Wheat is a major allergen; affected consumers should not consume the product.

    Product
    Item FLD1010A, Seasoned Peanut, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Peanut, Soy Sauce, Starch, Syrup, Cooking Oil
    Category
    Food
    Distribution
    1 state
  • 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
  • HighNHTSA·24V792000·2024-10-23

    Mack trucks with Bendix EC80 units may lose safety system functions

    Mack is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.

    Product
    MACK — MACK PINNACLE (PI/PN), ANTHEM (AN), GRANITE (GR), PIONEER PR (4)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0010-2025·2024-10-23

    Cisplatin Injection Vials Recalled for Failed Impurity and Degradation Standards

    Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.

    Product
    CISPLATIN — CISPLATIN (CISPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2025·2024-10-23

    Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling

    Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.

    Product
    MEDLINE HEART CABG CDS, REF CDS983376R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect

    Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.

    Product
    Monarch Inflation Device 30 atm/bar REF IN2130 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 al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2025·2024-10-23

    DiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall

    Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.

    Product
    DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
    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-0099-2025·2024-10-23

    Boston Scientific imaging system software error in grid overlay display

    Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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-0049-2025·2024-10-23

    KINOVA Jaco assistive robot recalled for potential fire hazard

    Kinova Inc is recalling 949 KINOVA Jaco assistive robots due to a potential fire hazard that may occur if a damaged robot arm interacts with a wheelchair exhibiting electrical leakage.

    Product
    KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2025·2024-10-23

    Boston Scientific AVVIGO+ Cardiac Imaging System Grid Display Error

    A software anomaly in Boston Scientific's AVVIGO+ system causes an incorrect 9-grid overlay to display instead of the correct 15-grid overlay when connected to OptiCross 18 catheters, potentially affecting clinical interpretation of vascular imaging.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; 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 (Food)·F-0028-2025·2024-10-23

    Premium Pistachio Grapenut Ice Cream Recalled for Undeclared Yellow 5 and Yellow 6 Dyes

    Today's Frozen Desserts, Inc. is recalling Premium Pistachio Grapenut ice cream sold in Florida because it contains undeclared Yellow 5 and Yellow 6 dyes. People sensitive to these food colorings should not consume the product.

    Product
    Premium Pistachio Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0086-2025·2024-10-23

    Leica Biosystems Cryostat lacks warning for flammable freezing spray use

    Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.

    Product
    Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2025·2024-10-23

    Boston Scientific AVVIGO+ Multi-Modality Guidance System Grid Display Software Defect

    Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - 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 modalitie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk

    Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
    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
  • HighFDA (Devices)·Z-0090-2025·2024-10-23

    Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays

    Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.

    Product
    Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2025·2024-10-23

    Duloxetine 20mg Delayed-Release Capsules Recalled for N-Nitroso Impurity

    Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V790000·2024-10-23

    Volvo trucks with Bendix EC80 units may lose safety system functions

    Volvo Trucks is recalling certain 2020-2025 trucks with Bendix EC80 Advanced Electronic Control Units because electrical noise may cause the ECU to misprocess commands or stop working.

    Product
    VOLVO — VOLVO VAH, VHD, VN, VNRE (ELECTRIC)
    Category
    Vehicle
    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 (Food)·F-0030-2025·2024-10-23

    Premium Grapenut Special Frozen Dessert Recalled for Undeclared Yellow 5 and 6

    Today's Frozen Desserts, Inc. is recalling Premium Grapenut Special frozen dessert sold in Florida because it contains undeclared Yellow 5 and Yellow 6 artificial colorants that are not listed on the label.

    Product
    Premium Grapenut Special, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • 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
  • HighNHTSA·24V789000·2024-10-23

    Kenworth and Peterbilt fuel pump barrels may fracture and leak

    PACCAR is recalling certain 2025 Kenworth and Peterbilt trucks with Cummins X15 diesel engines because the fuel pump barrels may fracture and cause a fuel leak.

    Product
    KENWORTH — KENWORTH, PETERBILT W900, 579, T680, C500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2025·2024-10-23

    Wilson-Cook Medical Recalls Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats

    Wilson-Cook Medical is recalling specific lots of Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats because they were manufactured with nonconforming raw materials.

    Product
    Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2025·2024-10-23

    Medtronic Vanta Neurostimulator Recall for Premature Battery Depletion

    Medtronic is recalling Vanta Implantable Neurostimulators (Model 977006) because battery life depleted faster than expected, leading to earlier surgical replacements or reprogramming.

    Product
    Vanta Implantable Neurostimulator (INS), Model 977006
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0058-2025·2024-10-23

    Merit Medical Recalls Monarch Inflation Devices Due to Sterile Barrier Breaches

    Merit Medical Systems is recalling 41,411 Monarch Inflation Devices because manufacturing defects caused holes in the sterile barrier.

    Product
    Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to mea
    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-0128-2025·2024-10-23

    Change Healthcare Cardiology Hemo Software Recalled for Calculation Errors

    Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.

    Product
    McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Grid Mark Display Error

    Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT 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
  • HighFDA (Devices)·Z-0130-2025·2024-10-23

    Nova Ortho-Med Rollator Backrest May Disengage During Position Adjustment

    Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2025·2024-10-23

    Merit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall

    Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.

    Product
    StabiliT TOUCH Syringe, REF: IN8VCF/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2025·2024-10-23

    basixTOUCH Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.

    Product
    basixTOUCH Inflation Device, REF: IN8140/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2025·2024-10-23

    Monarch Inflation Device Recalled Due to Sterile Barrier Breaches

    Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.

    Product
    Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
    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-0106-2025·2024-10-23

    Boston Scientific AVVIGO+ System Grid Overlay Display Software Error

    Boston Scientific AVVIGO+ Multi-Modality Guidance System displays incorrect grid overlay when connected to OptiCross 18 catheters in Live or Record mode due to a software anomaly. The wrong overlay could affect reference depth settings used in vascular imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whic
    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-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-0110-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Display Overlay Error

    Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT 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-0094-2025·2024-10-23

    Access TSH assay reagent packs may produce erroneously low results

    Certain lots of Beckman Coulter Access TSH reagent packs may produce erroneously low thyroid-stimulating hormone results. Affected kits should be verified before clinical use.

    Product
    The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2025·2024-10-23

    AVVIGO+ Multi-Modality Guidance System software defect causes incorrect grid display

    Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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
  • 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-0121-2025·2024-10-23

    Open Heart Surgical Kit Recalled for Incorrect Vessel Cannulae Model Labeling

    Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.

    Product
    MEDLINE OPEN HEART PACK, REF DYNJ66216C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Adjustment

    Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0117-2025·2024-10-23

    Graft Tube shaft may detach from funnel head during surgical use

    Spineology is recalling 190 Graft Tubes because the shaft may detach from the funnel head when not used as instructed, potentially compromising spinal surgical procedures.

    Product
    The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the impl
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0085-2025·2024-10-23

    Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays

    Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.

    Product
    Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2025·2024-10-23

    Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays

    Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.

    Product
    Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2025·2024-10-23

    Beckman Coulter Recalls Immunochemistry IGM Reagent Lots for Sensitivity Failure

    Beckman Coulter is recalling two lots of IGM reagent used in IMMAGE immunochemistry systems because they don't meet sensitivity specifications. The reagent measures immunoglobulin M levels in blood samples.

    Product
    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0122-2025·2024-10-23

    Medline Open Heart Surgical Kit Recall for Model Labeling Error

    Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.

    Product
    MEDLINE OPEN HEART, REF DYNJ904261B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0072-2025·2024-10-23

    basixTOUCH Inflation Device May Have Sterile Barrier Defect

    Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.

    Product
    basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0027-2025·2024-10-23

    Rum Nut Ice Cream Recalled Due to Undeclared Yellow 5 and Yellow 6

    Today's Frozen Desserts recalls Rum Nut Ice Cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. The recall affects 1,363 units with expiration dates from June 13 to September 13, 2025.

    Product
    Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0040-2025·2024-10-23

    Seasoned Sesame and Perilla Leaves Recalled for Undeclared Monosodium Glutamate

    Lemonland Food Corp is recalling Seasoned Sesame Leaves and Seasoned Perilla Leaves due to undeclared monosodium glutamate (MSG). The product was distributed in Washington.

    Product
    Item FLD1000AA, Seasoned Sesame Leaves or Seasoned Perilla Leaves, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Sesame Leaves, Red Pepper Powder, Malt Syrup, Soybean, Wheat, Anchovy, Salt, Carrots, Leeks, Garlic, Onion.
    Category
    Food
    Distribution
    1 state
  • 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-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 (Food)·F-0051-2025·2024-10-23

    El Gallo Azul Processed Cheese Recalled for Non-English Labeling

    El Gallo Azul Cock Brand Queso Procesado processed cheese in 300g metal cans is recalled for non-English labeling. The product was distributed in Oregon.

    Product
    El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-0029-2025·2024-10-23

    Premium Grapenut Frozen Dessert Recalled for Undeclared Food Coloring

    Today's Frozen Desserts is recalling Premium Grapenut frozen dessert products sold in Florida due to undeclared Yellow 5 and Yellow 6 food coloring additives not listed on product labels.

    Product
    Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0093-2025·2024-10-23

    Beckman Coulter Urine Chemistry Controls May Produce False Positive Results

    Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.

    Product
    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
    Category
    Medical Device
    Distribution
    0 states
  • 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-0026-2025·2024-10-23

    Rum Raisin Ice Cream Recalled for Undeclared Yellow 5 and Yellow 6

    Today's Frozen Desserts has recalled Rum Raisin ice cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. Approximately 1,363 units are affected.

    Product
    Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • 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 (Devices)·Z-0098-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

    Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which inc
    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
  • 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-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
  • 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 (Drugs)·D-0011-2025·2024-10-23

    Prescription Dapsone Gel 7.5% Recalled Due to Crystallization

    Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0124-2025·2024-10-23

    Medline Open Heart Kits Recalled Due to Incorrect Cannula Labeling

    Medline Industries is recalling 22 Open Heart NIMC Kits because they contain Medtronic DLP Vessel Cannulae that were incorrectly labeled during manufacturing.

    Product
    MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
    Category
    Medical Device
    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-0112-2025·2024-10-23

    Medical imaging system software defect causes incorrect grid overlay display

    Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT 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-0123-2025·2024-10-23

    Medical Device Kit Incorrectly Labeled With Wrong Model Number

    Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.

    Product
    MEDLINE KIT CV I II, REF DYNJ906071B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V784000·2024-10-21

    Vermeer Recalls 2024-2025 VXT600 G2 Vacuum Vehicles Due to Weld Defects

    Vermeer is recalling 2024-2025 VXT600 G2 vacuum vehicles because undersized welds on lift supports may fail, allowing the tank door to open and creating a road hazard.

    Product
    VERMEER — VERMEER VXT600 G2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V786000·2024-10-21

    Brinkley Model G solar panels may be wired to overload circuits

    Brinkley RV is recalling certain 2024-2025 Model G fifth wheel trailers because the solar panels may have been incorrectly wired, which can overload circuits and overheat wiring.

    Product
    BRINKLEY RV — BRINKLEY RV MODEL G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V785000·2024-10-21

    Triumph alternator harness wiring may short circuit and overheat

    Triumph is recalling certain 2022-2024 Bonneville and Scrambler motorcycles because the wiring between the alternator and main harness connector may short circuit and overheat.

    Product
    TRIUMPH — TRIUMPH STREET SCRAMBLER SANDSTOR, BONNEVILLE T120 BLACK, BONNEVILLE T100, BONNEVILLE T120
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V781000·2024-10-18

    Motiv Recalls 2021-2024 E-450 School Buses Due to Wire Connection Issue

    Motiv Power Systems is recalling 2021-2024 E-450 school buses because a loose wire connection could cause a loss of drive power, increasing crash risk.

    Product
    MOTIV — MOTIV E-450 BEV CHASSIS SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V779000·2024-10-18

    ATC Recalls Car Hauler and Stacker Trailers Due to Tongue Cracking

    ATC is recalling 2013-2025 Car Hauler and 2017-2025 Stacker trailers because stress may crack the A-frame tongue, potentially separating it from the trailer.

    Product
    ATC — ATC CAR HAULER, STACKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V774000·2024-10-18

    Forest River Recalls 2023-2024 Riverstone Fifth Wheel Trailers for Fire Risk

    Forest River is recalling 2023-2024 Riverstone Fifth Wheel trailers because incorrectly connected solar panels may cause wiring to overheat and melt, increasing the risk of a fire.

    Product
    FOREST RIVER — FOREST RIVER RIVERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V777000·2024-10-18

    Ford Recalls 2021 Mustang Mach-E for Brake System Software Update

    Ford is recalling 2021 Mustang Mach-E vehicles because an over-the-air update may disable power brake assist and stability controls, increasing crash risk.

    Product
    FORD — FORD MUSTANG MACH E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V773000·2024-10-18

    Mack Granite trucks recalled for non-DOT-tested tires

    Mack Trucks is recalling certain 2019–2025 Granite (GR) and 2018 Granite (GU) vehicles equipped with tires that may not have been DOT tested. The untested tires may fail, increasing crash risk.

    Product
    MACK — MACK GRANITE (GR), GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V780000·2024-10-18

    Mercedes-Benz Recalls 2025 GLB Models for Tire Sidewall Damage

    Mercedes-Benz is recalling 2025 GLB 250 and GLB 35 vehicles because tire sidewall damage may cause sudden pressure loss and loss of control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250, AMG GLB35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V783000·2024-10-18

    Rimac Nevera Recalled for Potential Electrical Cable Fire Risk

    Rimac is recalling 2023-2024 Nevera vehicles because a low-voltage cable may not be secured properly, posing a fire risk. Owners are advised not to drive until inspected.

    Product
    RIMAC — RIMAC NEVERA
    Category
    Vehicle
    Distribution
    Distributed nationwide

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