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.

6876–6900 of 52962

  • 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 (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-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-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 (Food)·F-0056-2025·2024-10-23

    Hungarian Mushroom Soup Recalled for Possible Presence of Larvae

    PCC Community Market's Hungarian Mushroom Soup is being recalled for possible presence of larvae. The affected product was distributed in Washington only.

    Product
    Hungarian Mushroom Soup sold at PCC Community Market as: (1) Sold in grab and go plastic retail container, net wt. 24 oz. UPC 20452200000. (2) Sold hot in self-serve soup bar. (3) Sometimes used as a sauce for Hungarian Meatballs served in some stores self-serve hot bar.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0053-2025·2024-10-23

    Dietary supplement with Rauwolscine recalled for potential Salmonella contamination

    Gorilla Mind Rauwolscine dietary supplement is recalled nationwide due to potential Salmonella contamination. Consumers should not use the product and contact the manufacturer.

    Product
    Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appetite, Increased Fat Loss, Increased Energy, dosage 3mg, 90 capsules per bottle, UPC 8 50017 02016 0. Product is manufactured for Gorilla Mind LLC 7154 W. State Street, STE 138, Boise, ID. Product label declares "***Suppl
    Category
    Food
    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-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-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 (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-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-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-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-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-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-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-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-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-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-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-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-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-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