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.

40876–40900 of 50511

  • HighFDA (Food)·F-2165-2014·2014-07-16

    Chocolate Squared Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Chocolate Squared Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Chocolate Squared Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2121-2014·2014-07-16

    Blueberry French Toast Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Blueberry French Toast with Bacon Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Blueberry French Toast with Bacon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2118-2014·2014-07-16

    Banana Nana Fofana Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Banana Nana Fofana Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Banana Nana Fofana Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2000-2014·2014-07-16

    Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration

    Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.

    Product
    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2002-2014·2014-07-16

    3M Attest Auto-reader Recalled for Missing Dry Natural Rubber Labeling

    3M is recalling Attest Auto-readers because labels failed to disclose dry natural rubber content, posing an allergy risk.

    Product
    3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2122-2014·2014-07-16

    Bonjour Toast Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Bonjour Toast Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Bonjour Toast Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2162-2014·2014-07-16

    Sunnyside Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Sunnyside Ice Cream because the bulk product lacked labels declaring ingredients and allergens.

    Product
    Sunnyside Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14E042000·2014-07-16

    Trans National Trading Recalls Outlaw T-70 XL Motorcycle Helmets

    Trans National Trading is recalling 486 Outlaw T-70 XL motorcycle helmets manufactured in August 2012 because they fail to comply with federal safety standards.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2014·2014-07-16

    Hospira MedNet Software Recall for Dosing Unit Transmission Defect

    Hospira is recalling 13 units of MedNet MMS software due to a defect that may fail to send specific dosing units to infusion pumps.

    Product
    The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2145-2014·2014-07-16

    Rocky Road Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Rocky Road Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Rocky Road Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2149-2014·2014-07-16

    Watermelon Sorbet Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Watermelon Sorbet because the product lacked required ingredient and allergen labels, including facility processing warnings.

    Product
    Watermelon Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2101-2014·2014-07-16

    Bourbon Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Bourbon Ice Cream because the product lacked required ingredient statements and allergen declarations.

    Product
    Bourbon Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2136-2014·2014-07-16

    Hazelnut Crunch Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Hazelnut Crunch Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Hazelnut Crunch Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2102-2014·2014-07-16

    Bourbon Maple Walnut Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Bourbon Maple Walnut Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Bourbon Maple Walnut Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2139-2014·2014-07-16

    Mexican Chocolate Ole Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Mexican Chocolate Ole Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Mexican Chocolate Ole Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2097-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Say "Cheeeeeesecake" Ice Cream because bulk product lacked labels declaring ingredients and direct allergens.

    Product
    Say "Cheeeeeesecake" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2026-2014·2014-07-16

    Steris 4085 General Surgical Table Recalled for Pressure Switch Defect

    Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.

    Product
    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2138-2014·2014-07-16

    Java Chip Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Java Chip Ice Cream because bulk products lacked labels declaring ingredients and allergens.

    Product
    Java Chip Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2158-2014·2014-07-16

    FDA Recalls Cookie Monster Dough Ice Cream for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Cookie Monster Dough Ice Cream because bulk products lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Cookie Monster Dough Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2025-2014·2014-07-16

    CareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter

    CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.

    Product
    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-2152-2014·2014-07-16

    Mocha Almond Fudge Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Mocha Almond Fudge Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Mocha Almond Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2150-2014·2014-07-16

    Simply Southern Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Simply Southern Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2094-2014·2014-07-16

    Cake Batter Up Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Cake Batter Up Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Cake Batter Up Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2134-2014·2014-07-16

    Gin and Juice Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Gin and Juice Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states