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.

25326–25350 of 50443

  • HighFDA (Devices)·Z-2057-2019·2019-07-31

    CooperSurgical LEEP Precision System Foot Pedal Function Defect Recall

    CooperSurgical is recalling LEEP Precision Integrated Systems because the foot pedal may fail to operate the cut, coagulate, or blend functions.

    Product
    LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2019·2019-07-31

    Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

    Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the sterility barrier.

    Product
    Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1512-2019·2019-07-31

    FDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk

    Deva Holding AS is recalling Temozolomide Capsules because manufacturing deviations allowed for possible cross-contamination with beta-lactam products.

    Product
    TEMOZOLOMIDE — TEMOZOLOMIDE (TEMOZOLOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2019·2019-07-31

    Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

    Cardinal Health is recalling specific lots of Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.

    Product
    Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannulas due to a manufacturing defect that could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannula, 20 G x 1-1/2" (Item code: 8881202363), because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2019·2019-07-31

    MOOG Curlin Infusion Administration Sets Recalled for Filter Leaks

    Zevex Incorporated is recalling specific lots of MOOG Curlin Infusion Administration Sets because they leaked at the filter.

    Product
    MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1999-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 444,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 1", Product Code 100211
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-1601-2019·2019-07-31

    Flowers Foods Recalls Hamburger Buns for Potential Hard Plastic Contamination

    Flowers Foods is recalling 47,878 packages of hamburger buns sold under multiple brands due to the potential presence of small pieces of hard plastic.

    Product
    Hamburger Buns soled under the brand names of: 7-ELEVEN 8CT, UPC 52548 00660 0; BRAVO 8CT, UPC 33755 85868 8; CBC NATHANS 8CT, UPC 72250 09366 8; CLOVER VALLEY 8CT, UPC 70210 00759 5; FAMILY STYLE 8CT, UPC 72250 02473 0; FOOD DEPOT 8CT, UPC 72250 02440 2; GREAT VALUE 8CT, UPC…
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2036-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Defect

    Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1594-2019·2019-07-31

    Jelly Belly Licorice Bridge Mix Recalled for Gluten Mislabeling

    Jelly Belly is recalling Licorice Bridge Mix because the packaging claims 'Gluten Free' but the ingredients list includes wheat flour.

    Product
    Jelly Belly Licorice Bridge Mix. Net Wt. 9 oz. (85g); 12 individual 3 oz. bags per caddy UPC: 071567981675 Manufactured by Jelly Belly Co., Fairfield, CA 94533
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V562000·2019-07-31

    Pierce Recalls 2019 Vehicles Due to Passenger Knee Air Bag Defect

    Pierce Manufacturing is recalling 174 specific 2019 models because the passenger-side knee air bag may not inflate properly during a crash, increasing injury risk.

    Product
    PIERCE — PIERCE IMPEL, ENFORCER, ARROW XT, DASH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2019·2019-07-31

    Terumo Medical Recalls 23G Needles Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 30,000 units of 23G x 1-inch needles (Lot 180811C) because a potential loss of package integrity may compromise the product's sterility.

    Product
    Terumo Needle, 23G x 1", Product Code NN2325R
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2076-2019·2019-07-31

    Laborie Medical Technologies Recalls U3-3 Solar Blue Power Supply Units

    Laborie Medical Technologies is recalling two U3-3 Solar Blue power supply units due to incorrect labeling and insulation material that does not meet flammability requirements, posing a potential fire hazard.

    Product
    U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1944-2019·2019-07-31

    National Frozen Foods Recalls Great Value Chopped Spinach for Listeria Risk

    National Frozen Foods is recalling Great Value Chopped Spinach due to potential Listeria monocytogenes contamination. The product was distributed in seven states.

    Product
    Great Value Chopped Spinach, packed in poly bags, net wt. 12 oz. 12 oz. bag UPC: 0 78742 23740 4. master case UPC: 3 00 78742 23740 5. The retail 12 oz. bag label is read in parts: "*** Great Value Chopped Spinach ***INGREDIENTS: SPINACH *** DISTRIBUTED BY: Walmart…
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2045-2019·2019-07-31

    Cardinal Health Recalls Monoject 201 Vet Pak Hypodermic Needles

    Cardinal Health 200, LLC is recalling Monoject 201 Vet Pak Hypodermic Needles due to a manufacturing defect that could compromise the product's sterility barrier.

    Product
    Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2019·2019-07-31

    Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Defect

    Cardinal Health is recalling Monoject 201 Vet Pak Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2019·2019-07-31

    Cardinal Health Recalls Monoject Blunt Cannula Due to Sterility Barrier Defect

    Cardinal Health 200, LLC is recalling Monoject Blunt Cannula 22 G x 1-1/2" (Item code: 8881202389) because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.

    Product
    Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
    Category
    Medical Device
    Distribution
    Distributed nationwide