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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6301–6325 of 27393

  • HighFDA (Devices)·Z-0946-2024·2024-02-07

    Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges

    Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.

    Product
    Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures

    American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2024·2024-02-07

    Knee implant component recalled due to potential material oxidation

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.

    Product
    SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2024·2024-02-07

    Knee replacement implant insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2024·2024-02-07

    Knee replacement tibial insert recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2024·2024-02-07

    Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment

    American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2024·2024-02-07

    Knee replacement implant recalled due to potential material degradation

    Howmedica Osteonics recalls DUR PCA MTK REV INS RT knee replacement implants due to potential oxidation of UHMWPE material that could compromise material properties. Patients should contact their healthcare provider.

    Product
    DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
    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-0795-2024·2024-01-31

    Bard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction

    C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.

    Product
    Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0781-2024·2024-01-31

    Medical X-Ray System Recall Due to Parts Falling Off

    Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.

    Product
    Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0787-2024·2024-01-31

    iQ Waste Well Adapter Recalled for Rust in Cannula Component

    Beckman Coulter recalls the iQ Waste Well Adapter due to rust in the cannula that may generate erroneous test results in laboratory diagnostic equipment.

    Product
    iQ Waste Well Adapter, Part Number: 700-3393
    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-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-0792-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

    C.R. Bard is recalling 17,250 Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate or reduced suction, decompression, and drainage during use. These tubes may not function properly for their intended medical purpose.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0803-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled Due to Reduced Suction and Drainage

    C.R. Bard is recalling 3,650 units of Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate suction, decompression, and drainage during use. The issue could affect proper tube function in clinical settings.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
    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-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-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-0788-2024·2024-01-31

    Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk

    Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.

    Product
    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0798-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

    C.R. Bard has recalled certain nasogastric sump tubes due to user reports of inadequate suction and drainage. The affected devices may fail to properly decompress the stomach.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
    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-0784-2024·2024-01-31

    Beckman Coulter DxU Analyzers Recalled for Potential Rust-Related Diagnostic Errors

    Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.

    Product
    Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
    Category
    Medical Device
    Distribution
    0 states
  • 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