The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6901–6925 of 52962

  • 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-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 (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-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-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-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-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-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-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
  • 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-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-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 (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 (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-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 (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
  • 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
  • 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·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·24V778000·2024-10-18

    2024 Ford Maverick Child Seat Tether Anchor Defect Recall

    Ford is recalling 2024 Maverick vehicles because the second-row child seat tether anchors may not properly secure a child seat due to incomplete thread engagement, increasing injury risk in a crash.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide