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.

30426–30450 of 50499

  • HighFDA (Food)·F-0332-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Almonds for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling Dark Chocolate Turbinado Sea Salt Almonds because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Turbinado Sea Salt Almonds , 15 lbs., 10 lbs., 18/14 oz.,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0139-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 573 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0124-2018·2017-11-29

    Halyard Closed Suction System Saline Vials Recalled for Leaking Risk

    Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing the contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0123-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0112-2018·2017-11-29

    Medline Pediatric Suction Catheters Recalled for Sterilization Error

    Medline Industries is recalling 190 units of pediatric elbow closed suction catheters because they were distributed before being sterilized.

    Product
    MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0322-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Cranberry for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling multiple Dark Chocolate Cranberry products because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Cranberry, 20 lbs., 25 lbs., 8/8 oz., 8 pc. display, 18/12 oz., 15 lbs., 2 NDS,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0134-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 893 Optetrak Offset Tibial Trays and Screws because of a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0119-2018·2017-11-29

    Halyard Closed Suction System Saline Vials Recalled for Potential Leaking

    Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0133-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech is recalling 801 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0336-2018·2017-11-29

    Shoreline Fruit Recalls Dark Chocolate Covered Cherries Due to Undeclared Milk

    Shoreline Fruit is voluntarily recalling dark chocolate covered cherries because the supplier recalled dark chocolate containing undeclared milk.

    Product
    Shoreline Fruit Dark Choc Covered Montmorency Cherries packaged in 25-pound corrugated box
    Category
    Food
    Distribution
    47 states
  • HighFDA (Food)·F-0401-2018·2017-11-29

    Ventura Foods Recalls SunGlow Margarine Due to Undeclared Soy Lecithin

    Ventura Foods is recalling SunGlow Unsalted European Style Butter Blend Margarine because it contains undeclared soy lecithin, a common allergen.

    Product
    SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g. Keep Refrigerated. UPC 26700-13499. Outer case: Net Wt 36 lb (16.32 kg). UPC 1 00 26700 13499 6. Ventura Foods, Brea, CA 92821
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0321-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Coffee Beans for Undeclared Milk

    GKI Foods is voluntarily recalling Dark Chocolate Coffee Beans because they may contain an undeclared milk allergen.

    Product
    Dark Chocolate Coffee Beans, 10 lbs., 15 lbs., 25 lbs., 12 pch Display, 8/8 oz., 12/10 oz., 12/8 oz.,
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0120-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaks

    Halyard Health is recalling specific lots of Closed Suction Systems because the saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0337-2018·2017-11-29

    Astor Chocolate Recalls Dark Chocolate Covered Cranberries for Undeclared Milk

    Astor Chocolate Corporation is recalling Dark Chocolate Covered Cranberries due to an undeclared milk allergen. The product was distributed across multiple US states and Canada.

    Product
    Astor Chocolate Corporation Brand Dark Chocolate Covered Cranberries in Astor or Customer Logo packaging a. 1 oz. giveaway type package sizing b. 4 oz. giveaway type package sizing c. No best by date on units d. Individual cases sold to Astor branded customers i. Case…
    Category
    Food
    Distribution
    22 states
  • HighCPSC·18046·2017-11-29

    Libbey Recalls Bourbon Taster Glasses Due to Laceration Hazard

    Libbey Glass is recalling approximately 229,000 Bourbon Taster Glasses because they can break during normal use, posing a laceration hazard.

    Product
    Bourbon Taster Glasses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0315-2018·2017-11-29

    GKI Foods Recalls Dark Chocolate Blueberries for Undeclared Milk Allergen

    GKI Foods is voluntarily recalling Dark Chocolate Blueberries because they may contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Dark Chocolate Blueberries 8/7 oz., 8 pc. display, 25 lbs.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0128-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech, Inc. is recalling 114 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0163-2018·2017-11-29

    Medline Plastic Transfer Belts Recalled for Locking Mechanism Failure

    Medline Industries is recalling 1,428 plastic transfer belts because the locking mechanism may fail, allowing the strap to slip through the buckle.

    Product
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2018·2017-11-29

    Medline Suction Catheters Recalled for Sterilization Error

    Medline Industries is recalling 120 units of sterile suction catheters that were distributed before being sterilized.

    Product
    MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0374-2018·2017-11-29

    Givaudan Recalls Natural Mirepoix Flavor Due to Metal Fragments

    Givaudan Flavours Corp is recalling Natural Mirepoix Flavor because the firm was notified of metal fragments in the product.

    Product
    NATURAL MIREPOIX FLAVOR 181.4 kgs/drum Ingredients: Carrot Juice, Celery Juice Concentrate, Dextrose, Autolyzed Yeast Extract, Onion Juice Concentrate, Cabbage Juice Concentrate, Salt, Natural Flavoring Givaudan Flavors Corporation 9500 Sam Neace Drive Florence, KY 41042
    Category
    Food
    Distribution
    1 state