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.

28126–28150 of 50462

  • HighFDA (Devices)·Z-2593-2018·2018-08-08

    MAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk

    Integra LifeSciences is recalling 17 MAYFIELD Infinity XR2 Base Units because the knob assembly may fracture during use.

    Product
    MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2018·2018-08-08

    Galt Medical Recalls Sterile Access Kits Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific sterile transcarotid and peripheral access kits because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1895-2018·2018-08-08

    Griffith Labs Herb Crouton Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 40 bags of Herb Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Herb Crouton Seasoning 50 pound bag Item 859021000
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1891-2018·2018-08-08

    Griffith Labs Garlic Cheese Crouton Seasoning Recalled for Salmonella Risk

    Griffith Labs U.S.A. is recalling Garlic Cheese Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Garlic Cheese Crouton Seasoning 50 pound bag Item 859086200
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1875-2018·2018-08-08

    Griffith Labs Recalls Chicken Fried Country Gravy Mix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Chicken Fried Country Gravy Mix because a whey ingredient used in the product was recalled for potential Salmonella contamination.

    Product
    Chicken Fried Country Gravy Mix 50 pound bag Item 1000013694
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2592-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units

    Integra LifeSciences is recalling 409 Mayfield Infinity XR2 Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1859-2018·2018-08-08

    Griffith Labs Dry Milk and Egg Mix Recalled for Salmonella Risk

    Griffith Labs U.S.A. is recalling Dry Milk and Egg Mix due to potential Salmonella contamination from a recalled whey ingredient.

    Product
    Dry Milk and Egg Mix 12 oz bag, 24 bags per carton Item 915004800
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1821-2018·2018-08-08

    Subco Foods Recalls Vanilla Yogurt Pouches Due to Salmonella Risk

    Subco Foods Inc. is recalling 1,010 cases of Only 8 Vanilla Yogurt because the whey used in the product was potentially contaminated with Salmonella.

    Product
    Only 8 Vanilla Yogurt 2.8 pound pouch 6 pouches per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1822-2018·2018-08-08

    Subco Foods Recalls Chocolate Yogurt Pouches Due to Salmonella Risk

    Subco Foods Inc. is recalling 357 cases of Only 8 Chocolate Yogurt because the whey used in the product was potentially contaminated with Salmonella.

    Product
    Only 8 Chocolate Yogurt 2.7 pound pouch 6 pouches per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1874-2018·2018-08-08

    Griffith Labs Recalls Sour Cream and Onion Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 200-pound drums of Sour Cream & Onion Snack Seasoning because a whey ingredient used in the product was previously recalled for potential Salmonella contamination.

    Product
    Sour Cream & Onion Snack Seasoning 200 pound drum Item 702083400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2018·2018-08-08

    Arrow International Recalls Percutaneous Sheath Introducer Kits Due to Latex Labeling Error

    Arrow International is recalling 60 units of Percutaneous Sheath Introducer Kits because the product contains dry natural rubber latex but is labeled as latex-free.

    Product
    Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2565-2018·2018-08-08

    Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1809-2018·2018-08-08

    Innova Flavors Recalls Natural Flavor Turkey Type Powder Due to Salmonella Risk

    Innova Flavors is voluntarily recalling Natural Flavor Turkey Type powder because a supplier's sweet whey powder is potentially contaminated with Salmonella.

    Product
    Natural Flavor Turkey Type, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2566-2018·2018-08-08

    Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1868-2018·2018-08-08

    Griffith Labs Cold Dough Premix Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling Cold Dough Premix due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Cold Dough Premix 6.8 pound bag, 6 units per carton Item 127033700
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2018·2018-08-08

    Siemens SOMATOM Scope Power Recalled for Software Radiation Risk

    Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Scope Power (Model 10967888)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1877-2018·2018-08-08

    Griffith Labs Clam Chowder Base Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling Clam Chowder Base due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Clam Chowder Base 2 pound 6 oz bag, 12 bags per case Item 860117400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1880-2018·2018-08-08

    Griffith Labs Recalls Butter Garlic Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Butter Garlic & Black Pepper Seasoning due to potential Salmonella contamination from a recalled whey ingredient.

    Product
    Butter Garlic & Black Pepper Seasoning 50 pound bag, Item 1000032662
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2018·2018-08-08

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Radiation Risk

    Siemens Medical Solutions is recalling SOMATOM Emotion 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Emotion 16 (10165977)
    Category
    Medical Device
    Distribution
    Distributed nationwide