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.

10501–10525 of 53042

  • HighFDA (Devices)·Z-0632-2024·2024-01-10

    Surgical Knife Crescent Recall Due to Incorrect Blade Angle

    Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.

    Product
    Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0635-2024·2024-01-10

    EDS 3 CSF External Drainage System recalled for incomplete sterility testing

    Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.

    Product
    EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2024·2024-01-10

    Xstar Kojo slit knife recalled for incorrect blade orientation

    One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.

    Product
    Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0628-2024·2024-01-10

    FDA Recalls Merit Pursue Microcatheter Due to Sterility Concerns

    Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.

    Product
    Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0663-2024·2024-01-10

    Bobo's Oat Bars Recalled for Undeclared Coconut Allergen

    Bobo's Oat Bars - Peach are recalled due to undeclared coconut. The recall affects approximately 10,800 units sold under Lot Code 3J27111.

    Product
    Bobo's Oat Bars - Peach 3oz packaged in ALOX coated PET film, corrugate cartons and master case. 12 units per carton
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0631-2024·2024-01-10

    Covidien Valleylab FT10 Energy Platform software issue causes inoperability

    Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.

    Product
    Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V011000·2024-01-10

    2022-2023 Lucid Air defrost heater failure reduces windshield visibility

    Lucid is recalling 2022-2023 Air vehicles whose high voltage coolant heater may fail to defrost the windshield, reducing visibility and increasing crash risk. Lucid will provide a software update and replace failed heaters at no cost.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0218-2024·2024-01-10

    Peritoneal Dialysis Solution Recalled for Lack of Sterility Assurance

    Fresenius Medical Care is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V010000·2024-01-10

    2024 Volvo XC40 Left Rear Turn Signal May Not Function

    Certain 2024 Volvo XC40 vehicles may have a software error in the Central Electronic Module that disables the left rear turn signal indicator, increasing the risk of a crash if other drivers are not notified of turning.

    Product
    VOLVO — VOLVO XC40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0711-2024·2024-01-10

    Racine Danish Kringles Raspberry Kringle Recalled for Undeclared Tree Nuts

    Racine Danish Kringles Raspberry Kringle (14 oz., lot 23299) is being recalled due to undeclared tree nuts (pecans). Consumers with nut allergies should not consume this product.

    Product
    Racine Danish Kringles Raspberry Kringle, 14 oz. UPC 0 45251-00312 7. RDK Corp, Racine, WI 53404.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0691-2024·2024-01-10

    Marinated Baby Milkfish Recalled for Botulism Risk Due to Missing Storage Instructions

    Foremost Foods is recalling Pamana Premium Marinated Baby Bangus due to potential botulism risk. The frozen product in reduced-oxygen packaging lacks required freezing and thawing instructions.

    Product
    Pamana Premium Marinated Baby Bangus (Deboned Marinated Baby Milkfish), Net Weight to be Weight at Time of Sale
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0639-2024·2024-01-10

    Spinal fixation screws recalled due to incorrect size laser marking

    Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.

    Product
    Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2024·2024-01-10

    Medtronic Protege GPS Stent System Recalled for Packaging Seal Defects

    Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.

    Product
    Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2024·2024-01-10

    Microcatheter and Infusion Systems Recalled Due to Sterility Concerns

    Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.

    Product
    Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0693-2024·2024-01-10

    Frozen Milkfish Recall Due to Missing Storage and Thawing Instructions

    Foremost Foods International is recalling Pamana Premium Bangus Belly frozen milkfish because the reduced-oxygen packaging lacks instructions to keep the product frozen and to thaw it properly, risking Clostridium botulinum toxin formation.

    Product
    Pamana Premium Bangus Belly (Cut Deboned Milkfish Belly), 340 g (120 oz)
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0689-2024·2024-01-10

    Seafood Medley Recalled for Potential Plastic Foreign Object

    Wegmans Seafood Medley (1 lb packages, Lot 47117) is being recalled because it may contain plastic foreign objects. The recall affects products distributed in Massachusetts, Pennsylvania, and New York.

    Product
    Wegmans Seafood Medley, 1lb.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0688-2024·2024-01-10

    Scratch PASTA Co Marinara Sauce Recalled for Unlabeled Milk Allergen

    Scratch PASTA Co Marinara Sauce is recalled because the label does not list milk as a common allergen, despite the product containing milk in its butter ingredient.

    Product
    Scratch PASTA Co MARINARA SAUCE NET WT. 24.5 oz glass jar Ingredients: San Marzano Plum Peeled Tomatoes, Onion, Butter (Cream, Natural Flavor) UPC 8 50053 68700 6 Scratch Pasta Company 2204 Bedford Avenue, Suite E Lynchburg, Virginia 24503
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0692-2024·2024-01-10

    Frozen marinated milkfish recalled due to botulism risk from missing storage instructions

    Foremost Foods International is recalling Pamana Premium Marinated Bangus due to potential botulism risk. The frozen product in reduced oxygen packaging lacks required freezing and thawing instructions.

    Product
    Pamana Premium Marinated Bangus (Deboned Marinated Milkfish), Net Weight to be Weight at Time of Sale
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0634-2024·2024-01-10

    External Drainage System Collection Bags Recalled for Sterility Assurance Issues

    Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.

    Product
    External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V009000·2024-01-09

    Alexis Fire Equipment Recalls 2022-2023 Fire Trucks Due to Electrical Fire Risk

    Alexis Fire Equipment is recalling 56 fire trucks from 2022-2023 because a firmware defect may prevent electrical circuits from shutting off, increasing fire risk.

    Product
    ALEXIS FIRE EQUIPMENT — ALEXIS FIRE EQUIPMENT FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V007000·2024-01-08

    Marion Body Works Recalls 2024 Spartan Fire MetroStar Vehicles for Brake Defect

    Marion Body Works is recalling 2024 Spartan Fire MetroStar vehicles because a defective inversion valve may delay parking brake engagement, increasing the risk of unintentional vehicle movement.

    Product
    MARION BODY WORKS — MARION BODY WORKS SPARTAN FIRE METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V005000·2024-01-08

    Coachmen Galleria motorhomes recalled for damaged wiring causing power steering loss

    Forest River is recalling Coachmen Galleria motorhomes (2020–2024) because battery boost wiring may become damaged, causing an electrical short circuit that results in loss of power steering, increasing crash risk.

    Product
    COACHMEN — COACHMEN GALLERIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V004000·2024-01-05

    Mickey Truck Bodies Recalls 37 Vehicles Due to Electrical Arcing Risk

    Mickey Truck Bodies is recalling 37 commercial trucks from 2020-2023 because exposed wiring on the refrigeration unit may cause electrical arcing and increase fire risk.

    Product
    MICKEY TRUCK BODIES — MICKEY TRUCK BODIES CHEVROLET 5500 HD, HINO L6, CHEVROLET LCF, FREIGHTLINER M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01042024-01·2024-01-05

    Frozen Mushroom Risotto Bites Recalled For Undeclared Sesame Allergen

    USDA FSIS issued a public health alert for Wild Fork Porcini Mushroom Risotto Bites that may contain undeclared sesame. Consumers with sesame allergies should not consume these products.

    Product
    FSIS Issues Public Health Alert For Frozen Mushroom Risotto Products Due To Misbranding And Undeclared Allergen
    Category
    Food
    Distribution
    11 states
  • HighCPSC·24075·2024-01-04

    Ride Aventon Sinch.2 Folding E-Bicycles Recalled for Unexpected Acceleration

    Ride Aventon is recalling about 2,300 Class 2 Sinch.2 folding e-bicycles because they can accelerate unexpectedly, causing loss of control and crash hazards. The firm has received six reports of unexpected acceleration but no injuries.

    Product
    Class 2 Sinch.2 Folding E-Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide