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 the agency’s own highest classification or reported deaths or serious injuries, 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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35651–35675 of 40449

  • HighFDA (Devices)·Z-1806-2014·2014-06-25

    RayStation Software Recall for Radiation Therapy Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software version 4.0.3.4 due to a bug that causes incorrect dose calculations for radiation therapy plans with variable CT slice spacing.

    Product
    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2014·2014-06-25

    Biomet G7 Acetabular System Positioning Guide Post Recalled for Fracture Risk

    Biomet is recalling G7 Acetabular System Positioning Guide Posts because the guide rod may fracture during surgery, potentially causing a delay in the procedure.

    Product
    G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2014·2014-06-25

    Philips Ingenia FlexTrak Trolley Recalled for Foot Clamping Hazard

    Philips is recalling Ingenia HA FLEX TRAK Trolleys because the central column can clamp a patient's foot. The recall covers 420 units distributed worldwide.

    Product
    Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2014·2014-06-25

    Spacelabs Ventilator Interface Recalled for Minute Volume Display Error

    Spacelabs Healthcare is voluntarily recalling Ventilator Flexport Interfaces because the bedside monitor may display minute volume values up to ten times the actual value.

    Product
    Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2014·2014-06-25

    ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Burn Risk

    ConMed Corporation is recalling Altrus Thermal Tissue Fusion Handpieces due to a risk of burns. The recall covers 12,653 units distributed worldwide.

    Product
    Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1808-2014·2014-06-25

    GE Healthcare Compact Airway Modules Recalled for Pump Failure Risk

    GE Healthcare is recalling Compact Airway Modules because a loose screw may cause pump failure, leading to loss of respiratory gas monitoring.

    Product
    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2014·2014-06-25

    Biomet Spine Cypher MIS Screw Inserter Recalled for Tip Failure

    Ebi, LLC is recalling 32 units of the Biomet Spine Cypher MIS Screw Inserter due to an increased rate of instrument tip failure.

    Product
    Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2014·2014-06-25

    Ability Dynamics Recalls RUSH81 Prosthetic Feet Due to Bolt Failure Risk

    Ability Dynamics is recalling 175 RUSH81 prosthetic feet because existing bolts may be bottomed out in threaded holes, which could lead to bolt failure.

    Product
    RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2014·2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products FS Calibrator 1

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Calibrator 1 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2014·2014-06-25

    Kerr Recalls Tytin Dental Restorative Material Due to Fast Setting

    Kerr Corporation is recalling one lot of Tytin Regular Set dental restorative material because it may set faster than specified in the Directions for Use.

    Product
    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2014·2014-06-25

    Elekta iGUIDE System Recalled Due to Software Logoff Bug

    Elekta, Inc. is recalling 224 iGUIDE Systems because a software bug prevents the system from logging off. The recall covers units distributed worldwide.

    Product
    iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2014·2014-06-25

    Elekta MOSAIQ software recall for unintended direction selection changes

    Elekta, Inc. is recalling MOSAIQ oncology software versions 1.40 through 2.50 because scrolling actions can unintentionally change direction selections.

    Product
    MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1791-2014·2014-06-25

    Roche cobas 6000 Analyzer Filters Recalled for Potential Aspiration Issues

    Roche Diagnostics is recalling cobas 6000 analyzer filters that may cause discrepant results and system alarms.

    Product
    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2014·2014-06-25

    Roche cobas 8000 Analyzer Filters Recalled for Potential Performance Issues

    Roche Diagnostics is recalling cobas 8000 analyzer filters that may cause discrepant results, alarms, or foam under certain conditions.

    Product
    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1834-2014·2014-06-25

    NIPRO Safe Touch Safety Scalp Vein Set Recalled for Potential Cracks

    Nipro Medical Corporation is recalling NIPRO Safe Touch Safety Scalp Vein Sets because a crack in the connector could cause fluid leakage.

    Product
    NIPRO Safe Touch Safety Scalp Vein Set
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1789-2014·2014-06-25

    Philips Smart Monitor 2 Professional Series Infant Apnea Monitor Recall

    Children's Medical Ventures is recalling 112 infant apnea monitors due to a battery wire harness defect that renders the devices inoperable.

    Product
    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1801-2014·2014-06-25

    Biomet Recalls EZPass Suture Retriever Due to Nitinol Wire Buckling

    Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.

    Product
    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1795-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling 968 IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2014·2014-06-25

    Biomet Recalls EZPass Nylon Monofilament Suture Passers Due to Buckling

    Biomet is recalling 100 units of EZPass Nylon Monofilament Suture Passers because the internal wire may buckle, making the instrument difficult to use.

    Product
    EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1790-2014·2014-06-25

    Roche MODULAR ANALYTICS EVO Serum Work Area Filter Recall

    Roche Diagnostics is recalling 462 Serum Work Area filters for the MODULAR ANALYTICS EVO analyzer due to potential loose components that may cause discrepant results and system alarms.

    Product
    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2014·2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 17

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 17 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2014·2014-06-25

    Boston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters

    Boston Scientific is recalling IntellaTip MiFi XP Temperature Ablation Catheters because some units were not manufactured according to specification.

    Product
    IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide