The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Any3+ (High and above)4+ (High and above)5+ (High and above)

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4851–4875 of 13543

  • 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-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-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-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 (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-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-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-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-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-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-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-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
  • ModerateFDA (Devices)·Z-0093-2025·2024-10-23

    Beckman Coulter Urine Chemistry Controls May Produce False Positive Results

    Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.

    Product
    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0120-2025·2024-10-23

    Medline Heart Overhead Table Pack recalled for incorrect model labeling

    Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.

    Product
    MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0112-2025·2024-10-23

    Medical imaging system software defect causes incorrect grid overlay display

    Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE 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
  • ModerateFDA (Devices)·Z-0109-2025·2024-10-23

    Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error

    Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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
  • ModerateFDA (Devices)·Z-0102-2025·2024-10-23

    Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error

    Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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
  • ModerateFDA (Devices)·Z-0123-2025·2024-10-23

    Medical Device Kit Incorrectly Labeled With Wrong Model Number

    Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.

    Product
    MEDLINE KIT CV I II, REF DYNJ906071B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0005-2025·2024-10-16

    Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect

    Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.

    Product
    Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
    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-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-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-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