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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6326–6350 of 27393

  • HighFDA (Devices)·Z-0791-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric decompression.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0794-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled due to inadequate suction and drainage

    C.R. Bard is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit due to user reports of inadequate suction, decompression, and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0772-2024·2024-01-31

    VITROS Anti-HBs Immunodiagnostic Products Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.

    Product
    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2024·2024-01-31

    TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System

    The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.

    Product
    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 51,750 Bard Nasogastric Sump Tubes with PreVent Anti-Reflux Filter due to reports of inadequate suction and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0797-2024·2024-01-31

    Bard Nasogastric Sump Tubes Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0782-2024·2024-01-31

    Hologic PANTHER FUSION System Recalled for Potential False Positive Flu B Results

    Hologic is recalling PANTHER FUSION nucleic acid testing systems due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2.

    Product
    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2024·2024-01-31

    Ultrasound Gel Sterility Cannot Be Guaranteed — FDA Recall

    Turkuaz Saglik Hizmetleri is recalling over 4.9 million units of sterile ultrasound gel (REF 126590) because manufacturer cannot guarantee its sterility. Affected products in Illinois and Hong Kong should not be used.

    Product
    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0785-2024·2024-01-31

    Beckman Coulter iQ200 Analyzers Recalled for Potential Rust and Diagnostic Errors

    Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.

    Product
    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0813-2024·2024-01-31

    Ultrasound system recalled due to measurement error in Dual Live Compare feature

    B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.

    Product
    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes due to user complaints of inadequate suction and drainage during use. Approximately 6,600 units were affected.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0802-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Inadequate Drainage

    C.R. Bard is recalling 3,360 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0783-2024·2024-01-31

    EliA GBM Diagnostic Wells Recalled for False Positive Results

    Phadia Ab recalls 124,928 EliA GBM Wells diagnostic kits distributed nationwide due to complaints of false positive results. The wells produced unexpected positive signals in samples tested without antigen.

    Product
    EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2024·2024-01-31

    C.R. Bard Nasogastric Sump Tubes recalled for inadequate drainage and suction

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to user reports of inadequate suction and drainage. The recall affects 16,564 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0805-2024·2024-01-31

    Bard Nasogastric Sump Tube ENFit recalled for inadequate drainage

    BD (C.R. Bard) is recalling Bard Nasogastric Sump Tubes with ENFit connectors because users have reported inadequate suction, decompression, and drainage. The devices may not function properly for their intended medical purpose.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0815-2024·2024-01-31

    FDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results

    DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.

    Product
    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0620-2024·2024-01-24

    Surgical Convenience Kit Recalled Due to Defective Component

    ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.

    Product
    regard Operative LAP, Item Number 800943001; surgical convenience kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0693-2024·2024-01-24

    Percussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled

    Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.

    Product
    Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0637-2024·2024-01-24

    Breathing Circuit Kits Recalled Due to Assembly Error Affecting Pressure

    Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kits due to assembly errors that can affect pressure output. The defect could impact respiratory support to patients using this device.

    Product
    High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
    Category
    Medical Device
    Distribution
    21 states
  • SevereFDA (Devices)·Z-0710-2024·2024-01-24

    FDA Recalls Express Chest Drain Blood Recovery Units Over Infection Risk

    Maquet Cardiovascular is recalling Express chest drain units with defective sterile water syringes. If not kept upright, patients risk exposure to infectious material that may cause infection, abscess, sepsis, or death.

    Product
    Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0709-2024·2024-01-24

    Express Chest Drains Recalled for Infection Risk from Recalled Syringes

    Maquet Cardiovascular is recalling Express chest drains pre-packaged with recalled sterile water syringes. If not kept upright, patients may be exposed to infectious material, risking infection, abscess, sepsis, and death.

    Product
    Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2024·2024-01-24

    Calibration Serum with Mis-assigned Alkaline Phosphatase Target

    Randox Calibration Serum Level 3 has an incorrect Alkaline Phosphatase target value (approximately 10% off) affecting clinical chemistry testing on RX Series instruments.

    Product
    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2024·2024-01-24

    SOLTIVE SuperPulsed Laser Fibers May Have Breached Sterile Pouch Seals

    Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.

    Product
    SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0735-2024·2024-01-24

    Intraocular Lens Cylinder Axis Marks Out of Specification

    Johnson & Johnson is recalling TECNIS Toric II intraocular lenses distributed in Japan. The cylinder axis marks do not meet product specifications and could affect vision correction.

    Product
    TECNIS Toric II OptiBlue IOL Models ZCW
    Category
    Medical Device
    Distribution
    0 states