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.

36201–36225 of 50504

  • HighNHTSA·16V200000·2016-04-08

    Bugatti Recalls Veyron Models Due to Inaccurate Fuel Gauge

    Bugatti is recalling 2006-2011 Veyron and Veyron Grand Sport vehicles because the fuel gauge may display more fuel than is actually in the tank, increasing the risk of stalling and a crash.

    Product
    BUGATTI — BUGATTI VEYRON, VEYRON GRAND SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V197000·2016-04-07

    Toyota Recalls 2016 Sienna Vehicles Due to Front Seat Belt Defect

    Toyota is recalling 2016 Sienna minivans because incorrect front seat belt height adjusters may tear or separate during a crash, increasing injury risk.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E031000·2016-04-07

    Soaring Recalls Vega XTV 7400 Helmets for Safety Standard Non-Compliance

    Soaring Helmet Corporation is recalling Vega XTV 7400 helmets that may not adequately protect users in a crash. Owners can exchange the helmets or receive a refund.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2016·2016-04-06

    PMBS S.C.O.R.E.S. Unit Recall Due to Potential Sterility Compromise

    PMBS, LLC is recalling 58 S.C.O.R.E.S. Units because water retention in filters may compromise sterility. The units were distributed to seven states.

    Product
    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0810-2016·2016-04-06

    Linda's Black Bean and Corn Salsa Recalled Due to Insanitary Conditions

    Flowers For Less is recalling Linda's Black Bean and Corn Salsa in 16 oz. glass jars because the product was produced under insanitary conditions following a security breach.

    Product
    Linda's Black Bean and Corn Salsa in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0807-2016·2016-04-06

    Linda's Salsa Mild Recalled Due to Insanitary Production Conditions

    Flowers For Less is recalling Linda's Salsa Mild in 16 oz. glass jars because they were produced under insanitary conditions following a security breach.

    Product
    Linda's Salsa Mild in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1258-2016·2016-04-06

    ICU Medical Recalls ChemLock I.V. Infusion Administration Sets

    ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1304-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2016·2016-04-06

    Siemens Artis zeego X-ray Systems Recalled for Mechanical and Electrical Defects

    Siemens is recalling 552 Artis zeego angiography systems due to risks of mechanical cable damage and high-voltage generator module failure.

    Product
    system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2016·2016-04-06

    Mitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error

    Mitsubishi Heavy Industries is recalling VERO MHI-TM2000 Linear Accelerators because the operator console may set an incorrect gantry angle for the first beam of an IMRT treatment.

    Product
    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2016·2016-04-06

    Terumo Recalls CDI Blood Parameter Monitoring System 500 for Temperature Errors

    Terumo is recalling 222 CDI Blood Parameter Monitoring System 500 devices because a faulty thermistor may cause inaccurate temperature and analyte readings.

    Product
    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0797-2016·2016-04-06

    Nestle Recalls Maggi Chicken Bouillon Tablets Due to Undeclared Wheat

    Nestle USA is recalling Maggi Chicken Flavor Bouillon tablets because they contain undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    MAGGI Chicken Flavor Bouillon 6Tab, 12Tab UPC Codes: 028000247959, 028000115678, 028000115678
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1259-2016·2016-04-06

    ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk

    ICU Medical is recalling specific IV infusion administration sets with ChemoLock ports because the connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1277-2016·2016-04-06

    Roche Estradiol II Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche Diagnostics is recalling the Elecsys Estradiol II assay because fulvestrant treatment causes falsely elevated estradiol results.

    Product
    Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2016·2016-04-06

    Ossur Recalls Papoose Infant Spine Immobilizers and Other Medical Devices

    Ossur Americas is recalling Papoose Infant Spine Immobilizers and other orthopedic devices due to a defect described as 'the p'.

    Product
    Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to…
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1265-2016·2016-04-06

    Biomet Vanguard XP Knee System Recall for Sizing Defect

    Biomet is recalling Vanguard XP Knee System porous femoral components because the AP dimension may be oversized, potentially causing loosening and revision surgery.

    Product
    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
    Category
    Medical Device
    Distribution
    0 states