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.

44426–44450 of 50511

  • HighNHTSA·12V554000·2012-11-30

    Medtec Recalls 2009-2011 Ambulances Due to Bench Top Screw Failure Risk

    Medtec is recalling 977 model year 2009-2011 ambulances because bench top screws may loosen and pull out, causing the bench top to drop and increasing the risk of personal injury.

    Product
    MEDTEC — MEDTEC AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V553000·2012-11-30

    Ford Recalls 2013 Fusion Vehicles for Headlamp Coating Defect

    Ford is recalling 2013 Fusion vehicles because improperly cured headlamp coatings may become hazy, reducing visibility and increasing crash risk.

    Product
    FORD — FORD FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12E054000·2012-11-29

    Cummins Recalls Diesel Engines in School Buses Due to Fan Pulley Defect

    Cummins is recalling specific ISB6.7 diesel engines installed in Thomas Built school buses because a fan pulley can fail, causing the engine to overheat and potentially disabling the vehicle.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2013·2012-11-28

    King Systems Recalls Child Silicone Laryngeal Airway Devices Due to Sterilization Indicator Defect

    King Systems Corp. is recalling 2,630 child silicone laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper EtO sterilization.

    Product
    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2013·2012-11-28

    Spacelabs Qube Compact Patient Monitor Recalled for Input Circuit Failure

    Spacelabs Healthcare is recalling Qube Compact Patient Monitors because the input circuit may fail, causing the device to shut down when batteries deplete or fail to turn on.

    Product
    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0428-2013·2012-11-28

    IMRIS OR Tables Recalled Due to Magnet Attraction Risk

    IMRIS is recalling ORT100 and ORT200 tables used in MRI systems because the foot end may be attracted to the magnet, posing a risk of injury to patients and operators.

    Product
    IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2013·2012-11-28

    Vital Signs Temperature Probe Recalled for Potential Nosebleed Risk

    Vital Signs Colorado Inc. is recalling 243,685 disposable temperature probes due to a potential risk of nosebleeds during use.

    Product
    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2013·2012-11-28

    Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth

    Biomet 3i is recalling 76 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, potentially preventing proper engagement of drivers or abutments.

    Product
    Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2013·2012-11-28

    Stryker Mantis Torque Wrench Recalled for Hex Tip Fracture

    Stryker Spine is recalling 19 Mantis Torque Wrenches because the hex tip may fracture during use. The recall covers units distributed in the US and internationally.

    Product
    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2013·2012-11-28

    Stryker XIA 3 Torque Wrench Recalled Due to Hex Tip Fracture

    Stryker Spine is recalling 54 XIA 3 Torque Wrenches because the hex tip may fracture during use, posing a risk of injury to patients or providers.

    Product
    Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2013·2012-11-28

    Sartori Mango Salsa Recalled for Possible Listeria Contamination

    Sartori Inspirations is recalling Mango Salsa due to possible Listeria monocytogenes contamination from recalled onion mixes.

    Product
    Mango Salsa packaged in 7 oz clear plastic containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic imaging systems due to a firmware issue affecting technique accuracy as mandated by regulations.

    Product
    GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure

    King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2013·2012-11-28

    SenTec V-Sign Membrane Changer Insert Recalled for Manufacturing Defect

    Sentec AG is recalling SenTec V-Sign Membrane Changer Inserts due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 sensor performance.

    Product
    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0377-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2013·2012-11-28

    SenTec V-Sign Membrane Changer Recalled for Manufacturing Defect

    Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 performance.

    Product
    SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0401-2013·2012-11-28

    Kerr Recalls BioPlant Dental Bone Grafting Material Due to Ossification Delay

    Kerr Corporation is recalling BioPlant dental bone grafting material because disturbing the product may halt or delay the ossification process.

    Product
    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13708·2012-11-28

    Kirkland Signature Sauté Pans Recalled Due to Glass Lid Laceration Hazard

    Meyer Marketing is recalling Kirkland Signature six-quart sauté pans sold at Costco because the tempered glass lids can crack or shatter, posing a laceration hazard.

    Product
    Kirkland Signature Six-Quart Sauté Pans with glass lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide