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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8526–8550 of 27393

  • HighFDA (Devices)·Z-1015-2023·2023-02-01

    Medical Device Manufacturer Recalls VAD Drive Kits With Expired Component

    Medline Industries is recalling 1,050 kits of Centurion Medical Products Silver Antimicrobial VAD Drive due to expired components. Affected kits were distributed across New York, Indiana, Florida, New Jersey, and Illinois.

    Product
    CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2023·2023-02-01

    Teleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction

    Teleflex is recalling approximately 497 endotracheal tubes worldwide due to potential failure of pilot balloon inflation or cuff deflation, which could interfere with airway management.

    Product
    Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Inse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2023·2023-02-01

    Endotracheal tubes recalled for potential pilot balloon and cuff malfunction

    TELEFLEX LLC recalls 39,690 endotracheal tubes for potential pilot balloon non-inflation or cuff non-deflation. These critical airway devices may not function properly during patient intubation.

    Product
    Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1003-2023·2023-02-01

    Siemens myNeedle Guide Software: Swapped Orientation Labels in CT Systems

    Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.

    Product
    Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2023·2023-02-01

    COVID-19 diagnostic test kits recalled for specimen leakage risk

    Meridian Bioscience is recalling 92 Revogene SARS-CoV-2 test kits due to potential specimen leakage from the cartridge, which could expose laboratory personnel to aerosolized COVID-19 virus.

    Product
    Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2023·2023-02-01

    Endotracheal Tubes May Fail to Inflate Pilot Balloon or Deflate Cuff

    TELEFLEX LLC is recalling 2,270 units of Slick Set Endotracheal Tubes due to potential pilot balloon non-inflation or cuff non-deflation. The devices were distributed worldwide including the United States.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2023·2023-02-01

    Oxford Partial Knee System Recalled for Compromised Sterile Barrier

    Biomet is recalling 7 units of the Oxford Partial Knee System due to improper packaging that compromises the sterile barrier. Incorrect carton sizing forced the device pouch to be folded, creating creases that breach the sterile protection.

    Product
    Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2023·2023-02-01

    FUSION Dual Pump Packs recalled for weld defect affecting surgery

    FUSION Dual Pump Packs are being recalled for weld defects that may impair vacuum delivery during eye surgery, risking surgical delays and corneal swelling. No injuries have been reported.

    Product
    FUSION Dual Pump Packs, REF: OPO73
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1009-2023·2023-02-01

    Abbott Alinity m System Nucleic Acid Testing Device Calibration Recall

    Abbott Molecular is recalling 918 Alinity m nucleic acid testing systems due to three identified potential calibration and configuration errors.

    Product
    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1017-2023·2023-02-01

    Invisalign Orthodontic Aligners Recalled for Software Defect Causing Incorrect Quantities

    Align Technology is recalling Invisalign Express 10, Comprehensive, and Moderate systems due to a software defect that may produce incorrect numbers of aligners and incorrect packaging.

    Product
    Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2023·2023-02-01

    Agfa HealthCare XERO Viewer Medical Imaging Software Class II Defect

    Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.

    Product
    Agfa HealthCare Enterprise Imaging XERO Viewer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1014-2023·2023-02-01

    MyDay Toric and Reveal 1 Day Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling MyDay Toric and Reveal 1 Day Toric contact lenses because some may have incorrect power, resulting in poor visual acuity. Consumers using affected lots should stop wearing the lenses and consult their eye care provider.

    Product
    MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
    Category
    Medical Device
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-0886-2023·2023-01-25

    Cardiosave IABP may shut down unexpectedly due to blood contamination

    The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0926-2023·2023-01-25

    Medical device controller software update addresses critical failure

    Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.

    Product
    SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0885-2023·2023-01-25

    Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2023·2023-01-25

    Patient table footrest may detach from AXIOM Luminos Agile

    Siemens Medical Solutions is recalling the AXIOM Luminos Agile patient table because the footrest may detach during use, creating a potential injury risk.

    Product
    AXIOM Luminos Agile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0993-2023·2023-01-25

    Cardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2023·2023-01-25

    Vasoshield Syringe Packs Recalled Due to Chipping Ink Risk

    Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.

    Product
    Vasoshield Syringe Packs, Model VH-5001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Performance Defects

    Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0977-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips that may impair drain function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2023·2023-01-25

    Jackson-Pratt Wound Drain Recalled for Performance Issues

    Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects

    Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-surgical wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Multiple Defects

    Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2023·2023-01-25

    Thoracic Stent-Graft System Recalled Due to Dimensional Defect

    Bolton Medical's RELAY PRO thoracic stent-graft system is being recalled because affected units may be shorter than their packaging indicates. The recall affects 129 units distributed worldwide.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide