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.

12751–12775 of 53082

  • HighFDA (Food)·F-1001-2023·2023-06-28

    FDA Recalls Earth Kratom Red Maeng Da Capsules for Unapproved Additive

    Fire Distributors Plus LLC is recalling Earth Kratom Red Maeng Da Kratom capsules because they contain kratom, an unapproved food additive. Approximately 31,600 pouches were distributed in the United States.

    Product
    EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES (UPC: 212223242796) (100 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1979-2023·2023-06-28

    Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk

    Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.

    Product
    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2023·2023-06-28

    Serrated Blade Applicator Kit packaging may contain wrong applicator size

    Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.

    Product
    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1983-2023·2023-06-28

    Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings

    Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.

    Product
    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-1003-2023·2023-06-28

    Frozen Waffles Recalled: Undeclared Soy Lecithin Allergen Risk

    Julian's Recipe Maple & Brown Butter Cauli-Wafels are being recalled due to undeclared soy lecithin. The product poses a risk to consumers with soy allergies.

    Product
    Julian's Recipe Maple & Brown Butter Cauli-Wafels, 7.41 oz.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0989-2023·2023-06-28

    TYR Anamix Early Years infant formula recalled for undeclared tyrosine

    Nutricia North America is recalling TYR Anamix Early Years infant formula due to undeclared tyrosine. The recall affects 94 cans distributed to 22 states and Puerto Rico.

    Product
    TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1987-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure

    Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.

    Product
    ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V452000·2023-06-28

    Certain 2021–2025 Lion LionC School Buses Electrical Hardware Recall

    Lion Electric is recalling 2021–2025 LionC school buses due to loose electrical hardware that could cause short circuits and loss of steering or braking power. Contact Lion customer service at 1-855-546-6706 for free replacement.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure

    Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.

    Product
    CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V449000·2023-06-28

    2022-2023 BMW I4 Recalled for High Voltage Battery Charging Unit Failure

    BMW recalls certain 2022-2023 I4, iX, and i760 models due to a defective high voltage battery charging unit that may not have been properly assembled, potentially causing engine stall while driving.

    Product
    BMW — BMW IX, I4, 760I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1002-2023·2023-06-28

    Julian's Recipe Cauli-Wafels recalled for undeclared soy allergen

    Julian's Recipe Original Cauli-Wafels are recalled due to undeclared soy lecithin. Consumers with soy allergies face risk of allergic reaction.

    Product
    Julian's Recipe Original Cauli-Wafels, 7.41 oz.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1754-2023·2023-06-28

    Implantable Cardiac Defibrillators May Deliver Reduced Energy Output

    Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.

    Product
    CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2023·2023-06-28

    KARL STORZ sterilization trays recalled for inadequate model-specific instructions

    FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.

    Product
    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V447000·2023-06-27

    2022-2024 Thor Motor Coach motorhomes recalled for detachable bike racks

    Thor Motor Coach is recalling certain 2022-2024 Tranquility and 2022-2023 Sanctuary motorhomes because the R-bike rack arms may fracture and detach, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TRANQUILITY, SANCTUARY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V448000·2023-06-27

    Lion LionC School Buses Surge Tank Defect May Cause Steering and Braking Loss

    Lion Electric is recalling 2019-2025 LionC school buses due to a surge tank support bracket defect. The tank may crack the firewall and damage high-voltage cables, potentially causing loss of steering assistance, drive power, and braking ability.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E048000·2023-06-27

    Eagle Eyes Recalls Aftermarket Headlights for Peterbilt 389 Vehicles

    Eagle Eyes is recalling specific aftermarket headlights for Peterbilt 389 vehicles because they may not provide sufficient light output, potentially reducing visibility and increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V444000·2023-06-26

    Fuel Pump Failure Risk in 2021-2023 Freightliner and Mercedes-Benz Sprinters

    Daimler Vans USA is recalling 2021-2023 Freightliner Sprinter and Mercedes-Benz Sprinter and Metris vehicles due to a fuel pump defect. The pump may shutdown, causing loss of drive power and increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 1500, METRIS, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V446000·2023-06-26

    2022–2023 Porsche 911 GT3 Rear Spoiler Control Software Error

    A software error in the rear spoiler control unit may cause brake lights to activate simultaneously on 2022–2023 Porsche 911 GT3 vehicles, potentially confusing other drivers.

    Product
    PORSCHE — PORSCHE 911 GT3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V445000·2023-06-26

    Mercedes-Benz Fuel Pump May Fail, Causing Loss of Drive Power

    Mercedes-Benz USA is recalling certain 2021–2023 vehicles with faulty fuel pumps that may shutdown and cause loss of drive power. Owners should contact dealers for free replacement.

    Product
    MERCEDES-MAYBACH — MERCEDES-MAYBACH, MERCEDES-BENZ S 680, S 580, S 580 4MATIC, S 500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V439000·2023-06-23

    2023 Lincoln Nautilus Brake System Risk from Defective Rear Shock Absorbers

    Ford is recalling 366 2023 Lincoln Nautilus vehicles due to incorrectly manufactured rear shock absorbers that may damage the brake hose, potentially extending stopping distance and increasing crash risk. Dealers will inspect and replace affected components at no cost.

    Product
    LINCOLN — LINCOLN NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V441000·2023-06-23

    Volvo Trucks Recall for Loose Steering Gear Fasteners

    Volvo Trucks is recalling 2023-2024 VN, VHD, and VAH trucks because steering gear fasteners may not be properly tightened, risking loss of vehicle control. Dealers will tighten the fasteners at no cost to owners.

    Product
    VOLVO — VOLVO VAH, VHD, VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23770·2023-06-22

    Infanttech Zooby Video Baby Monitors Recalled for Fire Hazard

    Infanttech is recalling about 17,100 Zooby video baby monitors for cars because the battery can malfunction, overheat, and burst, posing a fire hazard. The company has received three reports of the monitors catching fire, with no injuries reported.

    Product
    Zooby video baby monitors for cars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23227·2023-06-22

    Iron Dietary Supplements Recalled Due to Non-Child-Resistant Packaging

    Nationwide Pharmaceutical is recalling Ferrous Sulfate enteric-coated tablets because the packaging does not meet child-resistant requirements, posing a poisoning risk to young children. About 4,000 bottles were sold at major retailers from December 2022 through January 2023.

    Product
    Ferrous Sulfate (Iron) Enteric-Coated Tablets, 324 mg - 100 Tablet Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23769·2023-06-22

    Havertys Concord Dual Power Recliner Chairs Fall Hazard Recall

    About 930 Havertys Concord Dual Power Recliner Chairs are being recalled because the chair back can detach during use, posing a fall hazard. The firm has received nine reports of detachment, including two with reported injuries to the back, neck, and hip.

    Product
    Havertys Concord Dual Power Recliner Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide