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.

44501–44525 of 50511

  • HighFDA (Devices)·Z-0278-2013·2012-11-21

    Terumo HX2 Temperature Management System Recalled for Board Defects

    Terumo is recalling 19 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.

    Product
    HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2013·2012-11-21

    Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions

    Terumo CVS is recalling 312 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.

    Product
    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0684-2013·2012-11-21

    Whole Foods Shrimp Stir Fry Recalled for Undeclared Tree Nuts

    Whole Foods Market is recalling 164 units of Shrimp Stir Fry because the label fails to declare tree nuts (almond and cashews). The product was sold in Massachusetts, Connecticut, New York, and New Jersey.

    Product
    Whole Foods Meal Shrimp Stir Fry, 16 oz plastic container, Refrigerated, Product Code 3640630222
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0682-2013·2012-11-21

    Zatarain's Chicken Flavor Rice Mix Recalled for Undeclared Wheat

    McCormick & Company is recalling Zatarain's New Orleans Style Chicken Flavor Rice Mix because the product contains wheat but the label does not declare it.

    Product
    Zatarain's New Orleans Style Chicken Flavor Rice Mix, Item No. Z09705, packaged in 6.3 oz boxes, 12 boxes per carton, Box UPC: 7142901001
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·13706·2012-11-15

    John Deere Recalls Utility Vehicles Due to Fuel Filter Fire Hazard

    John Deere is recalling about 4,340 Gator utility vehicles with Kawasaki engines because the fuel filter can leak, posing a fire hazard. No injuries have been reported.

    Product
    Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13041·2012-11-15

    Kawasaki Recalls Lawn Mower Fuel Filters Due to Fire Hazard

    Kawasaki Motors is recalling fuel filters and tune-up kits for lawn mowers and utility vehicles because the filters can leak fuel, posing a fire hazard.

    Product
    Fuel Filters and Tune-Up Kits with Fuel Filters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V540000·2012-11-15

    Volkswagen Recalls 2012-2013 Beetles for Airbag Sensor Defect

    Volkswagen is recalling 2012-2013 Beetles with leather sport seats because a wet seat may prevent the airbag from turning off, increasing injury risk for children.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V539000·2012-11-15

    Volvo Bus 9700 Recalled for Wheelchair Lift Safety Pin Defects

    Prevost is recalling 44 Volvo Bus 9700 coaches because missing or inoperable wheelchair lift safety pins may prevent safe stowing, increasing injury risk.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13040·2012-11-15

    Kawasaki Recalls Lawn Mower Engines Due to Fuel Leak Fire Hazard

    Kawasaki Motors is recalling about 210,000 lawn mower engines because the fuel filter can leak, posing a fire hazard. No injuries have been reported.

    Product
    Lawn Mower Engines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V538000·2012-11-15

    Blue Bird Recalls 2013-2014 Vision School Buses Due to Brake Light Defect

    Blue Bird is recalling 452 model year 2013 and 2014 Vision school buses equipped with Ford 6.8L propane engines because the brake light switch may malfunction, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2013·2012-11-14

    Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error

    Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.

    Product
    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0268-2013·2012-11-14

    Kerr Recalls AlgiNot Dental Impression Material Due to Curing Defect

    Kerr Corporation is recalling AlgiNot dental impression material because it may cure harder than expected, potentially causing tooth fractures in patients with loose teeth.

    Product
    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0654-2013·2012-11-14

    Crab Tacos Recalled for Undeclared Allergens and Food Dye

    Fabrica Confecciones Soto, Inc. is recalling 180 units of "Tacos de Jueyes" (Crab Tacos) sold in Puerto Rico due to undeclared allergens and yellow #5.

    Product
    "Tacos de Jueyes" (Crab Tacos) - Food Service
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0258-2013·2012-11-14

    Kimberly-Clark Recalls MicroCool Sterile Surgical Gowns Due to Seal Defects

    Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.

    Product
    MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0603-2013·2012-11-14

    Kellogg's Mini-Wheats Cereal Recalled for Possible Metal Mesh Fragments

    Kellogg's is voluntarily recalling specific batches of Mini-Wheats cereal due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Canadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct; 400G, 510G, 850 G, 1300 G
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0655-2013·2012-11-14

    Crab-Filled Fritters Recalled for Undeclared Allergens

    Fabrica Confecciones Soto, Inc. is recalling 160 units of 'Alcapurria Jueyes' (crab-filled fritters) sold in Puerto Rico due to undeclared allergens.

    Product
    "Alcapurria Jueyes" (Crab-filled fritters) - Food Service
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0196-2013·2012-11-14

    Spacelabs Healthcare Recalls Xprezzon Bedside Monitor Touchscreen Displays

    Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.

    Product
    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0602-3013·2012-11-14

    Kellogg's Mini-Wheats Variety Packs Recalled for Metal Mesh Fragments

    Kellogg's is voluntarily recalling specific Mini-Wheats variety packs due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Kellogg's Variety and Assortment Packs containing Frosted/ Unfrosted Mini Wheats, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 10 ct; 30 ct, 72 ct , 96 ct.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2013·2012-11-14

    Sunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination

    Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.

    Product
    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
    Category
    Medical Device
    Distribution
    Distributed nationwide