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.

45326–45350 of 50512

  • HighCPSC·12238·2012-07-31

    Green Toys Recalls Mini Vehicles Due To Choking Hazard

    Green Toys is recalling approximately 52,500 mini vehicles sold in the U.S. and Canada because wheels and hubcaps can detach, posing a choking hazard to young children.

    Product
    Green Toys™ Mini Vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V368000·2012-07-27

    Rolls-Royce Ghost Recall for Incorrect Tire Information Label

    NHTSA recalls 2012 Rolls-Royce Ghost vehicles because the tire label incorrectly lists 19-inch tires instead of the installed 20-inch tires.

    Product
    ROLLS-ROYCE — ROLLS-ROYCE GHOST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2012·2012-07-25

    GE OEC 8800 Flexiview Imaging Device Recall for Defective Power Supply

    GE OEC Medical Systems is recalling OEC 8800 Flexiview imaging devices because an FDA inspection found a defective vertical lift column power supply subject to early life failure.

    Product
    OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2037-2012·2012-07-25

    Hitachi Scenaria CT System Software Recall for Reconstruction Error

    Hitachi is recalling Scenaria CT System software due to a defect that may cause incomplete image reconstruction, potentially resulting in missing diagnostic data.

    Product
    Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Network Power Failures

    Terumo is recalling 992 Advanced Perfusion System 1 units worldwide due to reports of communications and power failures in the system network.

    Product
    Terumo Advanced Perfusion System 1 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12T019000·2012-07-25

    Michelin Recalls BF Goodrich and Uniroyal Tires for Tread Separation

    Michelin North America is recalling specific BF Goodrich and Uniroyal tires due to a risk of tread/belt separation that could cause rapid air loss and increase crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V359000·2012-07-25

    Blue Bird Recalls 2013 School Buses Due to Seat Belt Defect

    Blue Bird is recalling 726 model year 2013 All American and Vision school buses because driver's seat belts may have mismatched buckles that fail to engage properly.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2012·2012-07-25

    Epocal Recalls BGEM Test Cards for Potential Low Glucose Results

    Epocal Inc is recalling 8,650 epoc Blood Analysis BGEM Test Cards because a portion of the lot may report inaccurate low glucose results.

    Product
    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2022-2012·2012-07-25

    LMA Esophageal Intubation Detector Recalled for Potential False Positive Readings

    LMA North America Inc is recalling 18,799 units of the LMA Esophageal Intubation Detector (EID100) because the device may produce false positive results during intubation confirmation.

    Product
    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2012·2012-07-25

    GE OEC Motorized C-Arm Systems Recalled for Defective Power Supply

    GE OEC Medical Systems is recalling OEC 9800 series motorized C-arm systems because a defective vertical lift column power supply is subject to early life failure.

    Product
    OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2049-2012·2012-07-25

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

    Terumo is recalling 81 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 100V. he 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-2044-2012·2012-07-25

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

    Terumo Cardiovascular Systems is recalling 274 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 115V. 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-2041-2012·2012-07-25

    Varian Eclipse Treatment Planning System Recall for Radiotherapy Prescription Errors

    Varian is recalling Eclipse Treatment Planning Systems because changing dose prescriptions in certain plans may result in incorrect Monitor Units and dose distributions.

    Product
    Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2012·2012-07-25

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

    Terumo is recalling 461 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, 4 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-2036-2012·2012-07-25

    Teleflex Medical Recalls Hudson RCI Concha Therm Neptune Humidifiers

    Teleflex Medical is recalling Hudson RCI Concha Therm Neptune Humidifiers because a speaker failure could prevent audio alarms from sounding, potentially delaying patient treatment.

    Product
    Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2012·2012-07-25

    GE OEC 9900 Elite C-arm System Recalled for Power Supply Defect

    GE OEC recalled 726 OEC 9900 Elite C-arm systems worldwide due to a defective vertical lift column power supply identified during an FDA inspection.

    Product
    OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2045-2012·2012-07-25

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

    Terumo is recalling 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, 5 pump 115V. The Sarns Modular Perfusion Systern 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
  • HighNHTSA·12V354000·2012-07-25

    Hyundai Recalls 2007-2009 Santa Fe Vehicles for Airbag Sensor Issue

    Hyundai is recalling 2007-2009 Santa Fe vehicles because the occupant classification system may fail to detect small adults, potentially preventing the front passenger airbag from deploying.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2012·2012-07-25

    Terumo Advanced Perfusion System 1 recalled for air bubble detection malfunctions

    Terumo is recalling 648 Advanced Perfusion System 1 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and oversensitivity.

    Product
    Terumo Advanced Perfusion System 1. System 1 base 220/240V. 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-2023-2012·2012-07-25

    EKOS MACH4 Endovascular Device Recalled for Catheter Marker Dislodgement

    EKOS Corporation is recalling EkoSonic MACH4 Endovascular Devices because radio-opaque marker bands may dislodge and the MicroSonic Device may break during use.

    Product
    EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2052-2012·2012-07-25

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

    Terumo is recalling 31 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, 100V 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-2010-2012·2012-07-25

    Terumo Advanced Perfusion System 1 Recalled for Network Communication Failures

    Terumo is recalling 648 Advanced Perfusion System 1 units due to reports of communications or power failures in the system network.

    Product
    Terumo Advanced Perfusion System 1 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2012·2012-07-25

    Stryker Recalls T2 Knee Arthrodesis Nails Due to Sterile Barrier Breach Risk

    Stryker is recalling 532 units of T2 Knee Arthrodesis Nails because of a potential breach in the sterile packaging barrier.

    Product
    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2012·2012-07-25

    Philips Brilliance CT Scanners Recalled for Defective Carbon Table Top Bolts

    Philips Medical Systems is recalling 524 Brilliance CT scanners because defective bolts securing the carbon table top may break off.

    Product
    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide