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.

25451–25475 of 50447

  • HighFDA (Devices)·Z-1930-2019·2019-07-10

    RaySearch Recalls Radiation Therapy Planning Software Due to Dose Calculation Errors

    RaySearch Laboratories AB is recalling RayStation and RayPlan software versions because electron Monte Carlo dose calculations may be incorrect when using a very large number of histories.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2019·2019-07-10

    GE Healthcare Recalls Centricity PACS Foundation Software

    GE Healthcare is recalling Centricity PACS Foundation software because it may allow users to view incorrect patient images from external archives.

    Product
    Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1525-2019·2019-07-10

    Will's Fresh Foods Macaroni Salad Recalled for Undeclared Wheat Allergen

    Woolery Enterprises Inc. is recalling Will's Fresh Foods Macaroni Salad because wheat is not declared as an ingredient or allergen.

    Product
    Will's Fresh Foods Macaroni Salad, All Natural; A true Classic salad made astonishingly delicious - semolina pasta, real mayonnaise and crunchy vegetables; NET WT. 12 oz.
    Category
    Food
    Distribution
    2 states
  • HighCPSC·19759·2019-07-10

    Office Depot Recalls Realspace Magellan Desks Due To Shock Hazard

    Office Depot is recalling about 19,000 Realspace Magellan Performance Electric Height-Adjustable Desks because a control box issue creates a shock hazard.

    Product
    Realspace® Magellan Performance Electric Height-Adjustable Desks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2019·2019-07-10

    Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2019·2019-07-10

    GE Healthcare Recalls Centricity Universal Viewer 6.0 Software

    GE Healthcare is recalling Centricity Universal Viewer 6.0 software due to a risk of displaying incorrect patient images from archives.

    Product
    Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift

    Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase results.

    Product
    VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19760·2019-07-10

    Bose Recalls Commercial Loudspeakers Due to Falling Injury Hazard

    Bose is recalling approximately 77,500 commercial loudspeakers because mounting components can break, causing the speakers to fall and pose an injury hazard.

    Product
    Professional use flush and surface mount loudspeakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19159·2019-07-08

    Disney Recalls Forky Plush Toys Due to Choking Hazard

    Disney is recalling approximately 80,000 Forky plush toys because the plastic eyes can detach, posing a choking hazard to young children.

    Product
    Forky 11" Plush Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V514000·2019-07-05

    Mazda Recalls 2019 Mazda3 Vehicles Due to Head Restraint Defect

    Mazda is recalling 2019 Mazda3 vehicles because seat cover material may prevent front head restraints from locking properly, increasing injury risk in a crash.

    Product
    MAZDA — MAZDA MAZDA3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2019·2019-07-03

    Hank's Cheesecakes Recalled for Missing Allergen and Ingredient Labels

    Hank's Cheesecakes, LLC is recalling 207 LoRusso Cakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    LoRusso Cake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1494-2019·2019-07-03

    Hank's Key Lime Cheesecakes Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling 207 Key Lime Cheesecakes because they were distributed without labels indicating ingredients or major food allergens.

    Product
    Key Lime Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1514-2019·2019-07-03

    Hank's Neapolitan Cheesecakes Recalled for Missing Allergen Labels

    Hank's Cheesecakes is recalling Neapolitan cheesecakes because the packaging lacks ingredient and major food allergen labels.

    Product
    Neapolitan Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1879-2019·2019-07-03

    GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk

    GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1522-2019·2019-07-03

    Euphoria Trading Recalls 70% Dark Chocolate Buttons for Undeclared Soy

    Euphoria Trading Company is recalling 70% Dark Chocolate Buttons due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    70% Dark Chocolate Buttons packaged in cellophane bags, zip bags (plastic bag with Ziploc closure), a bulk bin in the factory store. Net wt. 3 oz., 8 oz., 16 oz., 3 lbs (48 oz.) UPC on 3 oz. bag: 0 50469 05423 UPC on 8 oz. bag: 0 50469 05424 or 0 50469 05497 UPC on 16 oz.…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1867-2019·2019-07-03

    Thermo Fisher Isotemp Water Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling Isotemp 20L General Purpose Water Baths due to assembly errors that may cause the fluid temperature to exceed the user's set point.

    Product
    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1508-2019·2019-07-03

    Hank's Dreamsicle Cheesecake Recalled for Missing Allergen Labels

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

    Product
    Dreamsicle Cheesecake in a cardboard box labeled Hank's Cheesecake, St. Louis Missouri 63117
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1852-2019·2019-07-03

    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: ARD568811901 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling four 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 20L GP Bath Model Number: TSGP20
    Category
    Medical Device
    Distribution
    4 states