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.

9751–9775 of 22145

  • 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-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 (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 (Food)·F-0031-2025·2024-10-23

    King Harvest Spinach Hummus Recalled for Potential Plastic Fragments

    Pacific Coast Fresh CO is recalling 994 tubs of King Harvest Spinach Hummus due to potential plastic fragments. The hummus was distributed in Oregon and Washington with a use-by date of 10/08/24.

    Product
    King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108 7.
    Category
    Food
    Distribution
    2 states
  • 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-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-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-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
  • HighCPSC·25012·2024-10-17

    Oliva Cigars Recalls Slim Lighters Missing Child-Safety Feature

    About 60,000 promotional cigar slim lighters branded Nub, Serie V, Cain, and Oliva lack child-resistant mechanisms and pose fire and burn hazards to young children under age 5.

    Product
    Nub, Serie V, Cain, and Oliva branded Promotional Cigar Slim Lighters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25701·2024-10-17

    Arctic Cat and Tracker Off-Road Vehicles Recalled for Crash Hazard

    Textron Specialized Vehicles is recalling about 7,000 model year 2022–2024 Arctic Cat Prowler Pro and Tracker Off Road 800SX side-by-side vehicles because they can move while the digital dash displays "park," creating a rollaway crash hazard.

    Product
    Model Years 2022-2024 Arctic Cat Prowler Pro / Pro Crew and Tracker Off Road 800SX / 800SX Crew Side by Side Recreational Off Highway Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2025·2024-10-16

    Enterprise Imaging XERO Viewer medical software reference line placement error

    Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.

    Product
    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2025·2024-10-16

    Tonsil tray kits recalled for containing component under improper use recall

    Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.

    Product
    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2025·2024-10-16

    Endoscopy and Bronchoscopy Systems Power Cord Defect Risk

    Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.

    Product
    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2025·2024-10-16

    Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results

    The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.

    Product
    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2025·2024-10-16

    Respiratory Pathogen Panel Recalled Due to False Positive Results

    The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.

    Product
    NxTAG Respiratory Pathogen Panel, REF: I051C0447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0020-2025·2024-10-16

    Philips IntelliVue Patient Monitor Software Configuration Disables Enhanced ECG Alarms

    Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.

    Product
    IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indica
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0038-2025·2024-10-16

    3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination

    3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.

    Product
    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0023-2025·2024-10-16

    Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs

    The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.

    Product
    Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2025·2024-10-16

    GE Healthcare Centricity Universal Viewer may fail to display latest diagnostic report

    GE Healthcare Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x may fail to show the latest diagnostic report by default when a study contains multiple DICOM structured reports in different series.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0054-2025·2024-10-16

    MEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns

    Integra LifeSciences recalls MEDIHONEY Dressing applicator pouches due to potential pinholes that may compromise sterility. The recall affects approximately 120,124 units distributed across 36 US states and internationally.

    Product
    MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2025·2024-10-16

    FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode

    Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.

    Product
    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0033-2025·2024-10-16

    Medline Blood Pressure Monitor Recalled for Microchip Failure and Overheating

    Medline is recalling approximately 9,608 automatic digital blood pressure units due to a faulty microchip that causes power failures, display issues, and overheating.

    Product
    MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2025·2024-10-16

    Check-Flo Performer Introducer Set white caps may disconnect

    Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.

    Product
    Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
    Category
    Medical Device
    Distribution
    0 states