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.

4151–4175 of 52939

  • HighFDA (Food)·H-0212-2025·2025-07-09

    Vita Warehouse Vitamin B12 Gummies Recalled for Undeclared Peanut

    Vita Warehouse Corp. is recalling four Vitamin B12 gummy products nationwide due to undeclared peanut allergen. Consumers with peanut allergies should not use the affected products.

    Product
    1. Welby Vitamin B12 Adult Gummies 140 Count 2. Berkely Jensen¿ Vitamin B12 1000 mcg Gummies 250 count 3. VitaGlobe" Vitamin B12 Extra Strength Gummies 140 count 3. Vita Labs Vitamin B-12 Gummies Bulk 500 count
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2039-2025·2025-07-09

    VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.

    Product
    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V461000·2025-07-09

    Prevost Recalls 2018-2019 X3-45 Commuters for Incorrect Window Glazing

    Prevost is recalling 2018-2019 X3-45 Commuter vehicles because incorrect entrance door window glazing may reduce driver visibility and increase crash risk.

    Product
    PREVOST — PREVOST X3-45 COMMUTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2025·2025-07-09

    Medline IV Catheter Kits Recalled Over Needle Retraction Issue

    Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2025·2025-07-09

    Medline IV Catheters Recalled for Needle Retraction Failure

    Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0502-2025·2025-07-09

    Compounded lidocaine with epinephrine vials lack assurance of sterility

    Lidocaine HCl Sterile Injection 1% with epinephrine 1:100,000, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 2,825 vials affected.

    Product
    LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2025·2025-07-09

    Philips C9-5EC Ultrasound Transducer Devices Recalled

    Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips C9-5EC Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0500-2025·2025-07-09

    Compounded ketamine injection recalled over lack of sterility assurance concerns

    Ketamine Hydrochloride Injection compounded by Medivant Healthcare is being recalled for lack of assurance of sterility after an FDA inspection raised concerns about the sterile manufacturing process.

    Product
    KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2025·2025-07-09

    Cardiology hemodynamics software update may cause unexpected system shutdowns

    Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.

    Product
    Change Healthcare Cardiology Hemodynamics Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2025·2025-07-09

    BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors

    Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.

    Product
    REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Drugs)·D-0498-2025·2025-07-09

    Compounded preservative-free lidocaine vials lack assurance of sterility

    Preservative-free Lidocaine HCl Injection 1%, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 29,700 vials are affected.

    Product
    LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 8522
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0116-2025·2025-07-09

    Passion Fruit Mousse Recalled for Undeclared Allergens

    Sabores Fit Bakery is recalling Passion Fruit Mousse (8 oz cups) because the label fails to declare milk, eggs, soy, wheat, and tree nuts allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Passion Fruit Mousse, NET WT 8 OZ (230g), Sabores Bakery, Plastic Cups, 3.5-inch-wide x 3.75 in high, Keep refrigerated, PRODUCED EXCLUSIVELY BY: SABORES FIT BAKERY LLC. ORLANDO, FL 32836, UPC 7 35816 97176 2
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·25V454000·2025-07-07

    Land Rover Range Rover Evoque Passenger Air Bag Deployment Defect

    Jaguar Land Rover is recalling 2020–2025 Range Rover Evoque vehicles because the passenger air bag may tear during deployment, reducing occupant protection and risking burn injury from escaping gases.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V455000·2025-07-07

    Ford vehicles recalled for low-pressure fuel pump failure risk

    Ford is recalling certain 2021–2023 Ford and Lincoln vehicles because the low-pressure fuel pump may fail, causing engine stalls while driving and increasing crash risk.

    Product
    FORD — FORD, LINCOLN BRONCO, AVIATOR, F-150, F-550 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V376000·2025-07-07

    Kawasaki Ninja ZX-6R Motorcycles Engine Crankshaft Bushing Recall

    Kawasaki is recalling certain 2024–2025 Ninja ZX-6R motorcycles because the engine may lose power during operation due to crankshaft bushing seizure, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA ZX-6R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V452000·2025-07-07

    Shyft Recalls Utilimaster Truck Bodies Due to Signal Converter Failure

    Shyft Group is recalling 2015-2025 Utilimaster Truck Body vehicles because a signal converter failure can cause brake lights and turn signals to stop working.

    Product
    UTILIMASTER — UTILIMASTER TRUCK BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V453000·2025-07-07

    2025 Polestar 3 vehicles recalled due to water-damaged electrical connectors

    Polestar is recalling certain 2025 Polestar 3 vehicles because water may damage electrical connectors between the engine bay and front bumper, which can cause loss of power steering assist and increase crash risk.

    Product
    POLESTAR — POLESTAR POLESTAR 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25366·2025-07-03

    Predator 2000-Watt Power Stations Recalled for Electrical Shock Hazard

    Harbor Freight Tools is recalling about 6,500 Predator 2000-Watt Power Stations due to reversed wires in the AC outlet receptacles when in Emergency Power Supply mode, creating a shock hazard to consumers.

    Product
    Predator 2000W Power Stations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25374·2025-07-03

    509 Helmets Recalled Due to Risk of Head Injury

    509 helmets and 509 for Polaris helmets may fail to provide sufficient protection in a crash. One incident reported a helmet detachment during a crash resulting in a concussion.

    Product
    509 helmets and 509 for Polaris helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25371·2025-07-03

    Hyper Tough, Worx, and Portland Electric Chainsaws and Pole Saws Recall

    Positec is recalling about 49,000 Hyper Tough, Worx, and Portland brand electric corded chainsaws and pole saws due to a defective main switch that can fail and allow the saws to continue running, posing a laceration hazard.

    Product
    Hyper Tough, Worx and Portland Chainsaws and Pole Saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25369·2025-07-03

    Trane and American Standard Gas-Electric Packaged Units Recalled for Gas Leak Risk

    Trane U.S. Inc. recalls about 4,790 Gas/Electric Packaged Units because the fuel gas valve can open unexpectedly, causing a gas leak and fire hazard. No injuries have been reported.

    Product
    Trane and American Standard Gas/Electric Packaged Units
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25372·2025-07-03

    SNLN Party Supply Toys Recalled for Battery Ingestion Hazard

    SNLN Party Supply Toys containing button cell batteries are being recalled because the battery compartments can be easily opened by children, posing a risk of serious injury or death if swallowed.

    Product
    SNLN Party Supply Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide