The Recall Desk

State

New York product recalls

73,096 recalls have nationwide distribution and so reach New York. 12,938 additional recalls listed New York specifically in their distribution scope.

What the numbers show

Total
12,938
Critical
1,511
Severe
3,148
Most recent
2026-09-25

Of the 12,938 recalls naming New York we have scored against our rubric, 1,511 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3,148 (24%) are Severe.

These figures cover only the 12,938 recalls whose distribution notice names New York specifically. The 73,096 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10176–10200 of 86034

  • 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-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
  • 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-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 (Drugs)·D-0013-2025·2024-10-23

    First Aid Antiseptic Ointment Recalled for Mislabeled Inactive Ingredients

    Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.

    Product
    FIRST AID ANTISEPTIC — FIRST AID ANTISEPTIC (POVIDONE-IODINE)
    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-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-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-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-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-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-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
  • 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 PIONEER PR (4), PINNACLE (PI/PN), TERRAPRO (TE), ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Overlay Display Error

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

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 VNRE (ELECTRIC), VAH, VHD, VN
    Category
    Vehicle
    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-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 (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-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-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-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 (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-0056-2025·2024-10-23

    Olympus EVIS EXERA III Video System Recalled for Startup Failure

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

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