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.

10276–10300 of 86034

  • 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-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-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-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-0053-2025·2024-10-16

    Medline Sterile Laparoscopy Pack Recalled for Component Defect

    Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.

    Product
    Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2025·2024-10-16

    BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results

    BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.

    Product
    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2025·2024-10-16

    Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels

    Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.

    Product
    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0034-2025·2024-10-16

    MEDLINE Digital Blood Pressure Monitor Recalled Due to Microchip Faults

    MEDLINE is recalling 7,428 Automatic Digital Blood Pressure Monitors due to a faulty microchip causing power-on failures, display issues, and overheating. Units were distributed in the US, Panama, and Jamaica.

    Product
    MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0037-2025·2024-10-16

    FDA Recalls EPIONE Device Due to Internal Component Corrosion

    Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.

    Product
    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. Du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V768000·2024-10-16

    Multiquip Recalls Trailers Due to Frame Weld Cracking Risk

    Multiquip is recalling specific 2010-2016 trailers because frame welds may crack or break, reducing stability and increasing crash risk.

    Product
    MULTIQUIP — MULTIQUIP TRLR-55164, TRLR-57615, TRLR-55348
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0035-2025·2024-10-16

    Philips Patient Information Center iX Network Connectivity Issue Affects Settings Synchronization

    Philips Patient Information Center iX devices may fail to synchronize settings when network DHCP leases expire during offline operation, causing the devices to receive new IP addresses that are not recognized after reconnection.

    Product
    Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0050-2025·2024-10-16

    StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

    Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

    Product
    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2025·2024-10-16

    MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error

    Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.

    Product
    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2025·2024-10-16

    Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch

    Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.

    Product
    Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2025·2024-10-16

    Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall

    Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.

    Product
    Aligned Medical Tonsil ENT Pack REF AMS9977 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
  • ModerateFDA (Devices)·Z-0029-2025·2024-10-16

    Aligned Medical Septo Pack recalled for containing component under FDA recall

    The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

    Product
    Aligned Medical Septo Pack REF AMS11480 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
  • ModerateFDA (Devices)·Z-0030-2025·2024-10-16

    Aligned Medical T and A Pack Recalled for Component Misuse Risk

    Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.

    Product
    Aligned Medical T and A Pack REF AMS11482 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
  • ModerateFDA (Devices)·Z-0040-2025·2024-10-16

    Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch

    FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.

    Product
    Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2025·2024-10-16

    iCast Covered Stent Recalled for Unique Device Identifier Labeling Error

    Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.

    Product
    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2025·2024-10-16

    Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component

    Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.

    Product
    Aligned Medical Tonsil Pack REF AMS14809 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