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.

25501–25525 of 50447

  • HighFDA (Devices)·Z-1892-2019·2019-07-03

    Hitachi PROBEAT-V Proton Therapy System Software Recall

    Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.

    Product
    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1501-2019·2019-07-03

    Hank's Cheesecake Recalls Chocolate Amaretto Torte for Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Chocolate Amaretto Tortes because the packaging lacks ingredient and major food allergen information.

    Product
    Chocolate Amaretto Torte in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1870-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling four units of the General Purpose Dynamic Bath due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1862-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head fork coating may crack, posing a risk of particles falling into the surgical field and causing patient infection.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling five VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1503-2019·2019-07-03

    Hank's Cheesecakes Recalls Triple Play Cake Due to Missing Allergen Labels

    Hank's Cheesecakes, LLC is recalling 207 Triple Play Cakes because the packaging lacks ingredient and major food allergen information.

    Product
    Triple Play Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1496-2019·2019-07-03

    Hank's Cheesecakes Recalls Unlabeled Carrot Cakes for Missing Allergen Info

    Hank's Cheesecakes, LLC is recalling 207 carrot cakes sold in Missouri and Illinois because the packaging lacks ingredient and allergen labels.

    Product
    Carrot Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1860-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2019·2019-07-03

    AtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal

    AtriCure is recalling 497 units of the EPi-Sense Guided Coagulation System because the sterile package seal may be compromised, posing a risk of infection.

    Product
    EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2019·2019-07-03

    GE Healthcare Recalls Centricity PACS-IW Universal Viewer Software

    GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because medical images may be missing without warning.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2019·2019-07-03

    GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk

    GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling two Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1858-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling six VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2019·2019-07-03

    Hank's Irish Cream Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Irish Cream Cheesecakes because the packaging lacks ingredient and major food allergen information.

    Product
    Irish Cream Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·19E044000·2019-07-03

    DLT Recalls CravenSpeed Fiat Short Shifter Shafts for Breakage Risk

    DLT, LLC is recalling CravenSpeed Fiat Short Shifter shafts for 2011-2019 Fiat 500 vehicles because improper manufacturing may cause the shaft to break, increasing crash risk.

    Product
    FIAT — FIAT 500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2019·2019-07-03

    Thermo Fisher Isotemp Water Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling five Isotemp 10L General Purpose Water Baths due to an assembly error that may cause the fluid temperature to rise above the set point.

    Product
    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1504-2019·2019-07-03

    Hank's Double Chocolate Cheesecake Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Double Chocolate Cheesecakes because the packaging lacks ingredient and major food allergen information.

    Product
    Double Chocolate Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1868-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling 12 General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to exceed the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1890-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
    Category
    Medical Device
    Distribution
    Distributed nationwide