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.

31901–31925 of 50502

  • HighFDA (Devices)·Z-2629-2017·2017-07-05

    Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage

    Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.

    Product
    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2400-2017·2017-07-05

    Mikawaya Recalls Red Bean Ice Cream Due to Metal Fragments

    Mikawaya is recalling Shirakiku Brand Red Bean Ice Cream 3 gallon foodservice tubs due to the possibility of metal fragments.

    Product
    Shirakiku Brand Red Bean Ice Cream 3 gallon foodservice tub
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2653-2017·2017-07-05

    Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks

    Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2017·2017-07-05

    Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors

    Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.

    Product
    SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2017·2017-07-05

    Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect

    Carestream Health Inc is recalling DRX-Revolution Mobile X-Ray Systems because missing screws could cause the tube and yoke assembly to separate.

    Product
    DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2017·2017-07-05

    Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2396-2017·2017-07-05

    Hans Kissle Cranberry Couscous Recalled for Undeclared Cashews

    Hans Kissle Company is recalling Whole Foods Cranberry Couscous because it contains undeclared cashews, a major food allergen.

    Product
    Whole Foods Cranberry Couscous- packaged in Clear plastic clamshell for 6oz, 14oz and 18oz, and white plastic pail for 10lb. UPC Codes: 036217162613(6oz), 036217162514(14oz), 036217261408(18oz), 036217110317(10lb)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2624-2017·2017-07-05

    Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2634-2017·2017-07-05

    Mindray Recalls TI Transport Monitor Battery Packs Due to Overheating

    Mindray is recalling 2,718 TI Transport Monitor battery packs because two reports indicated the packs overheated.

    Product
    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2017·2017-07-05

    Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

    Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

    Product
    Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2017·2017-07-05

    Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure

    Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.

    Product
    MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2017·2017-07-05

    Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue

    Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.

    Product
    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2017·2017-07-05

    Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks

    Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2017·2017-07-05

    Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

    Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

    Product
    MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2017·2017-07-05

    Recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector

    Covidien LLC is recalling 194,851 units of the Endo Peanut 5mm Auto Suture Blunt Dissector because the cotton tip may disengage due to insufficient adhesive.

    Product
    Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2017·2017-07-05

    Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks

    Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.

    Product
    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V425000·2017-07-03

    Toyota Recalls Tacoma and 4Runner Vehicles with Detaching Hood Scoops

    Southeast Toyota Distributors is recalling 2011-2016 Toyota Tacoma and 4Runner vehicles because accessory hood scoops may detach, creating a road hazard.

    Product
    TOYOTA — TOYOTA TACOMA, 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V426000·2017-07-03

    Triumph Recalls 2017-2018 Street Cup Motorcycles for Wiring Defect

    Triumph is recalling 2017-2018 Street Cup motorcycles because the hazard light wiring harness may strain during steering, potentially causing the lights to fail and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH STREET CUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V419000·2017-06-30

    KZRV Recalls 2018 Sportsmen LE Trailers Due to Improper Spare Tires

    KZRV is recalling 2018 Sportsmen LE recreational trailers because they were supplied with spare tires of incorrect size and load capacity, which may fail if used while fully loaded.

    Product
    KZRV — KZRV SPORTSMEN LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V422000·2017-06-30

    Jayco Recalls 2017 Hummingbird Travel Trailers Due to Incorrect Tire Labels

    Jayco is recalling 2017 Hummingbird travel trailers because tire labels list incorrect pressure requirements, which could lead to tire failure and crashes.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER HUMMINGBIRD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V414000·2017-06-29

    GM Recalls 2014 Chevrolet Silverado and GMC Sierra for Steering Assist Loss

    General Motors is recalling 2014 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because they may experience a temporary loss of electric power steering assist, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide