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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8176–8200 of 40007

  • HighFDA (Devices)·Z-0899-2024·2024-02-07

    Knee Replacement Component Recalled Due to Material Oxidation Risk

    Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.

    Product
    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2024·2024-02-07

    Series II Tibial Bear Insert Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2024·2024-02-07

    Urological procedural kits recalled due to sterilization defects

    American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2024·2024-02-07

    MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk

    Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.

    Product
    Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2024·2024-02-07

    Surgical needle holders distributed with incorrect product labels

    Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.

    Product
    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0966-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration

    Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2024·2024-02-07

    TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation

    MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.

    Product
    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0964-2024·2024-02-07

    Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue

    Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.

    Product
    MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0837-2024·2024-02-07

    FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy

    Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.

    Product
    Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2024·2024-02-07

    Medline Blood Culture Kits recalled for inaccurate expiration dating

    Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2024·2024-02-07

    Medline Blood Culture Tray Adult recalled for incomplete component labeling

    Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.

    Product
    MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
    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-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-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-0789-2024·2024-01-31

    Snapshot NIR Tissue Oxygenation System Touchscreens May Be Unresponsive

    Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.

    Product
    Snapshot NIR, REF: KD204
    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-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-0778-2024·2024-01-31

    Accure Laser System recalled due to spot tracking misalignment risk

    Accure Acne, Inc. is recalling the Accure Laser System Model PFMS00004 because its spot tracking system may misalign, potentially delivering higher-than-expected laser energy that could cause blistering.

    Product
    Accure Laser System, Model: PFMS00004
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0804-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage

    C.R. Bard Inc is recalling 8,010 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction, decompression, and drainage.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0806-2024·2024-01-31

    Bard Suction Connector with ENFit Recalled for Inadequate Drainage

    C.R. Bard is recalling 133,610 Bard Suction Connectors with ENFit (model EN0066000) due to user complaints of inadequate suction and drainage. No injuries have been reported.

    Product
    Bard¿ Suction Connector with ENFit, REF EN0066000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0801-2024·2024-01-31

    Nasogastric Valve Recalled for Reduced Suction and Drainage

    C.R. Bard Inc. is recalling approximately 187,550 Bard Lopez Valve units due to user complaints of inadequate suction, decompression, and drainage during use. No illnesses or injuries have been reported.

    Product
    Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
    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-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