The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

45351–45375 of 50512

  • HighFDA (Devices)·Z-2033-2012·2012-07-25

    Stryker AVS Navigator Trials Recalled for Shaft Failure

    Stryker Spine is recalling AVS Navigator Trials because the shaft may fail at the junction of the trial head.

    Product
    Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2012·2012-07-25

    GE Healthcare Recalls Invasive Blood Pressure Care Cables

    GE Healthcare is recalling 279 invasive blood pressure care cables due to a faulty O-ring that prevents correct blood pressure monitoring.

    Product
    GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1769-2012·2012-07-25

    SunOpta Oat Fiber Recalled for Possible Cronobacter sakazakii Contamination

    SunOpta Ingredients Group is voluntarily withdrawing specific lots of Canadian Harvest Oat Fiber 300-33 due to possible contamination with Cronobacter sakazakii.

    Product
    SunOpta, Canadian Harvest Oat Fiber, Oat Fiber 300-33, Manufactured by SunOpta Ingredients, Chelmsford, MA 01824
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2042-2012·2012-07-25

    Terumo Advanced Perfusion System Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 992 Advanced Perfusion System I units worldwide due to reported malfunctions in the Air Bubble Detection System, including oversensitivity and false alarms.

    Product
    Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 310 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2012·2012-07-25

    Alere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy

    Alere San Diego is recalling 9,997 Triage Tox+MTD Drug Screen kits because they may produce false positive or negative results due to decreased precision and accuracy.

    Product
    Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2012·2012-07-25

    Kimberly-Clark Recalls MicroCool Surgical Gowns Due to Fabric Defects

    Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood to pass through.

    Product
    MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions

    Terumo Cardiovascular Systems is recalling 286 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12V362000·2012-07-25

    Micro Bird Recalls G5 School Buses for Roof Hatch Friction Issues

    Micro Bird is recalling 2011-2012 G5 school buses because roof escape hatches may be too hard to open, potentially hindering emergency egress.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Power Malfunction

    Terumo is recalling 992 Advanced Perfusion System 1 units due to a power loss error message that may affect system stability during medical procedures.

    Product
    System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2012·2012-07-25

    Kimberly-Clark Recalls MicroCool Surgical Gowns Due to Material Defects

    Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood strikethrough, potentially compromising sterility.

    Product
    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2012·2012-07-25

    Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions

    Terumo is recalling 484 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.

    Product
    Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2012·2012-07-25

    Spacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection

    Spacelabs Healthcare is recalling 21 Xprezzon Bedside Monitors because specific key presses can cause patient parameters to disappear from the display.

    Product
    Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2021-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Power Fluctuation Errors

    Terumo is recalling 648 Advanced Perfusion System 1 units due to a Red X error indicating loss or fluctuation of internal power on one side of the base.

    Product
    System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1770-2012·2012-07-25

    Truitt Brothers Navy Beans Recalled for Undeclared Soy Allergen

    Truitt Bros. Inc. is recalling 95 cans of Pacific Northwest Premium Navy Beans due to undeclared soy. The product was distributed to California, Oregon, and Washington.

    Product
    Truitt Brothers, Pacific Northwest Premium Navy Beans, net weight 15 oz. per metal can. The UPC is 0 82225 24145 1. The product is labeled in parts: "***TRUITT BROTHERS***Pacific Northwest PREMIUM NAVY BEANS***NET WT 15 OZ***INGREDIENTS: NAVY BEANS, WATER, SEA SALT, NATURAL…
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·12V352000·2012-07-24

    Hyundai Recalls 2012-2013 Sonata Vehicles Due to Airbag Defect

    Hyundai is recalling 2012-2013 Sonata vehicles because the curtain side airbags may inflate without a deployment command, increasing the risk of injury and driver distraction.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V349000·2012-07-24

    Blue Bird Recalls 2013 Vision School Buses for Brake Indicator Defect

    Blue Bird is recalling 19 model year 2013 Vision school buses because a missing electronic module may prevent the brake pressure warning light from activating.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V348000·2012-07-23

    Elkhart Transit Buses Recalled for Roof Hatch Egress Issues

    Elkhart Coach is recalling 2011 transit buses because roof escape hatches may not open easily in an emergency, increasing injury risk.

    Product
    ELKHART — ELKHART 9215-0200, 9250-0700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12229·2012-07-19

    Downeast Concepts Recalls Children's Beach Chairs Due to Laceration Hazard

    Downeast Concepts is recalling about 15,400 children's folding beach chairs because exposed sharp metal rivets pose a laceration hazard. One injury involving stitches has been reported.

    Product
    Folding Beach Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V345000·2012-07-19

    Collins Recalls 2012 School Buses Due to Fuel Hose Damage Risk

    Collins Bus Corporation is recalling 598 model year 2012 school and activity buses because the fuel filler hose may be damaged by seat bolts, creating a fire risk.

    Product
    CORBEIL — CORBEIL, MID-BUS, COLLINS DH516, SH400, DH416, DH500
    Category
    Vehicle
    Distribution
    Distributed nationwide