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.

35101–35125 of 50502

  • HighFDA (Food)·F-1732-2016·2016-07-27

    Keebler Mini Sandies Shortbread Cookies Recalled for Undeclared Peanut

    Kellogg Company is recalling Keebler Mini Sandies Shortbread cookies due to potential undeclared peanut allergen from a flour supplier issue.

    Product
    Keebler Mini Sandies Shortbread cookies, 100 ct., 1.0 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-1724-2016·2016-07-27

    Kellogg Recalls Keebler Fudge Cookies Due to Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Keebler E. L. Fudge Double Stuffed Sandwich Cookies because they may contain undeclared peanut.

    Product
    Keebler E. L. Fudge Double Stuffed Sandwich Cookies, 12 ct., 12 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-1736-2016·2016-07-27

    Kellogg Recalls Gripz Variety Packs Due to Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Gripz Variety On the Go Packs because they may contain undeclared peanut, a common allergen, due to a supplier's flour recall.

    Product
    Gripz Variety On the Go Pack, 14 pack, 12.6 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-1733-2016·2016-07-27

    Kellogg Recalls Famous Amos Chocolate Chip Cookies for Undeclared Peanut

    Kellogg Company is voluntarily recalling Famous Amos Chocolate Chip Cookies due to potential undeclared peanut allergen from a flour supplier issue.

    Product
    Famous Amos Cookies Chocolate Chip, 12 ct., 12.4 oz.; and 2.7 oz. cup
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2221-2016·2016-07-27

    WalkMed Infusion Recalls Spike Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling 12-inch Microbore Spike Sets due to the potential presence of particulate matter in or on the devices.

    Product
    Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1737-2016·2016-07-27

    Kellogg Recalls Keebler Animal Totes for Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Keebler Animal Totes due to a potential undeclared peanut allergen resulting from a supplier's flour recall.

    Product
    Keebler Animal Totes, bulk tote 400 lb.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Drugs)·D-1364-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate

    PharMEDium Services is recalling 4,081 bags of 0.1% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2016·2016-07-27

    WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence

    WalkMed Infusion is voluntarily recalling Triton Administration Sets because they may contain particulate matter. The recall affects 383 cases distributed nationwide.

    Product
    T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter on or in the devices.

    Product
    T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2016·2016-07-27

    Parker Trach-Vac Endotracheal Tubes Recalled Due to Tube Kinking During Use

    Parker Medical is voluntarily recalling Trach-Vac Endotracheal Tubes because they may kink during use, potentially affecting patient ventilation.

    Product
    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1738-2016·2016-07-27

    Kellogg Recalls Keebler 5 Flavor Mod for Undeclared Peanut

    Kellogg Company is voluntarily recalling Keebler 5 Flavor Mod snack items because they may contain undeclared peanut. The recall stems from a supplier's recall of flour.

    Product
    Keebler 5 Flavor Mod
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2222-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1721-2016·2016-07-27

    Kellogg's Special K Mini Brownies Recalled for Undeclared Peanut

    Kellogg Company is voluntarily recalling Special K Mini Brownies Blondie due to potential undeclared peanut from a flour supplier issue.

    Product
    Kellogg's Special K Mini Brownies Blondie, 6 ct, 4.44 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2254-2016·2016-07-27

    Roche Recalls cobas EGFR Mutation Test V2 Due to False Negatives

    Roche Molecular Systems is recalling cobas EGFR Mutation Test V2 kits because internal studies found they may produce false negative results when used with the cfDNA Sample Preparation kit.

    Product
    cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2235-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of T100-000VF IV sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16232·2016-07-27

    Novel Laboratories Recalls Zolpidem Tartrate Tablets for Packaging Defect

    Novel Laboratories is recalling Zolpidem Tartrate sublingual tablets because the packaging fails to meet child-resistant closure requirements, posing a risk of poisoning to children.

    Product
    Zolpidem Tartrate Sublingual tablets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1730-2016·2016-07-27

    Kellogg Recalls Keebler Grahams Crackers Honey Due to Undeclared Peanut

    Kellogg Company is voluntarily recalling Keebler Grahams Crackers Honey in 200-count and 30-count cases because of potential undeclared peanut.

    Product
    Keebler Grahams Crackers Honey 200 CT, 2-pk, 0.49 oz., and 30 CT 5.33 oz.,10 Lb. cases
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2226-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

    WalkMed Infusion, LLC is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide