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.

40451–40475 of 50511

  • HighFDA (Devices)·Z-2635-2014·2014-09-24

    JK Products Recalls Sun Dash Radius 252 Tanning Beds Due to Electrical Hazard

    JK Products & Services is recalling 1,948 Sun Dash Radius 252 tanning beds because excessive flexing of the main electrical cord can compromise wire integrity.

    Product
    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2014·2014-09-24

    Varian 4D Integrated Treatment Console Recall for Safety Interlock Defect

    Varian Medical Systems is recalling 512 4D Integrated Treatment Consoles because user error can allow improper clearing of safety interlocks.

    Product
    4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Concerns

    Bio-Detek is recalling 198 cases of ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2457-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Cranberry Royale Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Cranberry Royale frozen dessert because the packaging does not list ingredients, posing a risk to consumers with food allergies.

    Product
    Cranberry Royale- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2463-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Forest Berry Sorbet for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Forest Berry Sorbet because the frozen dessert packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Forest Berry Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2653-2014·2014-09-24

    Mitsubishi Vero Linear Accelerator Software Recall for Treatment Status Errors

    Mitsubishi Heavy Industries is recalling three Vero Linear Accelerator systems in the US due to a software defect that may incorrectly mark completed radiation treatments as untreated.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000; 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
    3 states
  • HighFDA (Devices)·Z-2567-2014·2014-09-24

    Varian C-Series Linear Accelerators Recalled for Beam Output Decrease

    Varian Medical Systems is recalling C-Series High Energy Linear Accelerators due to a trend of unexpected decreases in beam output during 6MV photon treatment.

    Product
    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2014·2014-09-24

    Volcano TrakBack II Disposable Pullback Device Recalled for Sterility Concerns

    Volcano Corporation is recalling TrakBack II Disposable Pullback Devices because internal testing identified a potential breach to the sterile barrier that may impact product sterility.

    Product
    Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2014·2014-09-24

    Becton Dickinson Recalls Vancomycin Screen Agar Due to False Resistance Results

    Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the product may allow susceptible bacteria to grow, leading to false resistance test results.

    Product
    BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2660-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues

    Bio-Detek is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V595000·2014-09-24

    Elkhart Coach Recalls Ford E-Series Vans with Ricon Wheelchair Lifts

    Elkhart Coach is recalling 2006-2014 Ford E-350 and E-450 vans equipped with specific Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk.

    Product
    FORD — FORD E-450, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1588-2014·2014-09-24

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira Inc. is recalling 75,000 vials of Bupivacaine Hydrochloride 0.5% due to a confirmed report of a brown, rust-colored particle embedded in the glass vial.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2659-2014·2014-09-24

    ZOLL Pro-padz Sterile Adult Electrodes Recalled for Sterility Assurance Issues

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Sterile Adult Multi-Function Electrodes because the sterility of the devices is not assured.

    Product
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2456-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Cocoa Zin Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Cocoa Zin frozen dessert because the packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Cocoa Zin- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2443-2014·2014-09-24

    Japanese Specialty Food Distributors Recalls Frozen Ground Tuna for Scombroid Illness

    Japanese Specialty Food Distributors is recalling 961 cases of frozen ground tuna from Indonesia due to an association with scombroid illness. The product was distributed to Connecticut, New York, New Jersey, Texas, and Georgia.

    Product
    JSF Ground Tuna - IQF - Origin: Indonesia - 2/11LB, frozen
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2643-2014·2014-09-24

    Siemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias

    Siemens is recalling ADVIA Chemistry A1c_3 Calibrators because they may cause a percent bias in HbA1c test results.

    Product
    ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2652-2014·2014-09-24

    ArjoHuntleigh Recalls Tenor Mobile Passive Lifts Due to Bolt Breakage Risk

    ArjoHuntleigh is recalling Tenor mobile passive lifts because the spreader bar bolt may break during use, posing a risk to patients and caregivers.

    Product
    Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V590000·2014-09-23

    Daimler Recalls 2015 Minotour School Buses for Electrical Fuse Defect

    Daimler Trucks North America is recalling 2015 Minotour school buses because using hazard and brake lights simultaneously may blow a fuse, disabling both systems and increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14279·2014-09-23

    Hearth & Home Technologies Recalls Gas Fireplaces Due to Gas Leak Risk

    Hearth & Home Technologies is recalling about 20,000 gas fireplaces, stoves, inserts, and log sets because the gas valve can leak, posing a fire hazard.

    Product
    Gas fireplaces, gas stoves, gas inserts and log sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V585000·2014-09-23

    Jayco Recalls 2015 Jay Flight Travel Trailers Due to Fire Risk

    Jayco is recalling 114 model year 2015 Jay Flight travel trailers because inadequate venting from the range could allow propane gas to accumulate and ignite, causing a fire.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V584000·2014-09-23

    National Van Recalls Ford E-Series Vans with Cracking Wheelchair Lifts

    National Van is recalling 2007-2014 Ford E-150 and E-250 vans equipped with specific Ricon wheelchair lifts. The platform side plates may crack, causing the lift to fall and injure the operator.

    Product
    FORD — FORD E-250, E-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V587000·2014-09-23

    NABI Transit Buses Recalled for Missing Wheelchair Lift Interlock

    NABI is recalling 2012 31LFW and 2008-2013 416 transit buses because they may lack a transmission interlock for wheelchair lifts, posing an injury risk.

    Product
    NABI — NABI 31LFW, 416
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V581000·2014-09-22

    Nissan Recalls 2014 Infiniti Hybrid Vehicles Due to Software Error

    Nissan is recalling 2014 Infiniti Q50 and Q70 hybrid vehicles because a software error may cause the electric motor to stop working, increasing crash risk.

    Product
    INFINITI — INFINITI Q70 HYBRID, Q50 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide