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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8626–8650 of 27441

  • 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-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-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-1005-2023·2023-02-01

    Veritas Advanced Infusion Packs Recalled Due to Weld Gap Defect

    Johnson & Johnson Surgical Vision is recalling Veritas Advanced Infusion Packs for a weld defect that may impair vacuum delivery during ophthalmic surgery. This could result in surgical delays and transient corneal swelling.

    Product
    Veritas Advanced Infusion Packs, REF: VRT-AI
    Category
    Medical Device
    Distribution
    8 states
  • 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-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
  • 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-1021-2023·2023-02-01

    biokitHSV-2 Rapid Test Recalled for Potential False Positive Results

    The biokitHSV-2 Rapid Test has been recalled due to the potential for false positive results. The recall affects approximately 2,393 test kits distributed across NY, CA, IN, NC, and VA.

    Product
    biokitHSV-2 Rapid Test, REF: 300028001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1002-2023·2023-01-25

    X-ray imaging system footrests may detach from patient tables

    Siemens Luminos X-ray imaging systems may have a footrest that detaches from the patient table during use. The manufacturer is recalling 886 units distributed worldwide.

    Product
    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0992-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling 22,847 units of Jackson-Pratt Channel Drains due to performance issues including dull trocars, broken tips, lack of flexibility, and lack of radiopacity.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled due to performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 3,520 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
    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-0995-2023·2023-01-25

    Vasoshield Syringe Ink Chips May Cause Embolic Events

    Ink on the Vasoshield syringe may chip off, potentially causing blood clots and foreign body reactions in patients. About 9,817 devices are affected.

    Product
    Hemopro 2 with Vasoshield, Model VH-4001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Issues

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. No injuries have been reported.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
    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-0976-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2225) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 4,112 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2023·2023-01-25

    Jackson-Pratt Surgical Drain Recalled Due to Performance Defects

    Cardinal Health is recalling 4,372 Jackson-Pratt Channel Drains due to multiple performance issues: lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0975-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain recalled for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm, model JP-2212) due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2023·2023-01-25

    Mobile CT Scanner Injury Risk During Reverse Transport

    Mobius Imaging recalls the MobiCT-32 AIRO Mobile CT Scanner after one untrained user was injured while moving the unit in reverse. The manufacturer will add warning labels to improve instructions for safe reverse transport.

    Product
    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
    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