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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9976–10000 of 13717

  • 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-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-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-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-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-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-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-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
  • ModerateFDA (Devices)·Z-1019-2023·2023-02-01

    Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device

    SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.

    Product
    Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1013-2023·2023-02-01

    Baxter ELI 380 Electrocardiograph Recalled After Misdirected Shipment

    Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.

    Product
    Baxter Electrocardiograph, ELI 380 -DCS21
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1020-2023·2023-02-01

    AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy

    SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.

    Product
    AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2023·2023-02-01

    Intraoperative PTH Test Kits Recalled Due to High Result Variability

    Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.

    Product
    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    7 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-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-0974-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. About 1,768 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2023·2023-01-25

    Cardinal Health Jackson-Pratt Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (15 Fr, REF JP-2228) due to multiple performance issues including dull trocars, broken wound tips, lack of radiopacity, and inflexibility. The recall affects approximately 15,493 units distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain: Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple reported performance defects including dull trocars, lack of flexibility, missing radiopacity, and broken tips. These issues may compromise insertion and drain function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2023·2023-01-25

    ARTIS medical imaging systems recalled for mechanical connection failure

    Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.

    Product
    ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (7mm, REF JP-2210) for performance issues including lack of radiopacity, dull trocars, poor flexibility, and broken tips. Affected units may not function properly.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0985-2023·2023-01-25

    Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The recall affects 7,129 units distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
    Category
    Medical Device
    Distribution
    Distributed nationwide