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.

11301–11325 of 53044

  • HighNHTSA·23V711000·2023-10-20

    New Flyer Transit Buses Recalled for Incorrect Weight Rating Labels

    New Flyer is recalling 2021-2023 transit buses because incorrect weight rating labels may allow vehicles to be overloaded, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XE40, XD35, XDE35, XD60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V710000·2023-10-20

    2024-2025 Lion School Buses Recalled for Brake System Installation Defect

    Lion Electric is recalling certain 2024-2025 LionC school buses due to incorrect installation of anti-lock brake system pneumatic valve connections and rear wheel speed sensors, which can cause wheel lockup or loss of vehicle control.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V707000·2023-10-20

    BMW Recalls 157,796 Vehicles for Potential Engine Stall Risk

    BMW is recalling 157,796 vehicles from 2010-2012 because aluminum bolts securing the VANOS unit may loosen or break, potentially causing an engine stall and increasing crash risk.

    Product
    BMW — BMW X5, Z4, 3 SERIES, 1 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24704·2023-10-19

    Polaris RZR Recreational Off-Road Vehicles Recalled for Crash Hazard

    Polaris is recalling certain 2023 and 2024 RZR recreational off-road vehicles because an improperly routed brake line can contact the front wheels, causing brake loss and crashes. Consumers should immediately stop using the vehicles and contact a Polaris dealer for a free inspection and repair.

    Product
    Model Year 2023 RZR PRO XP and PRO XP 4 and Model Year 2024 RZR XP and XP 4 ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V702000·2023-10-19

    Altec Recalls 2023 Digger Derricks Due to Gearbox Defect

    Altec is recalling 2023 Digger Derricks because a defective brake flange casing may cause the turntable rotation gearbox to fail at high loads, increasing the risk of injury.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V704000·2023-10-19

    2022-2024 Honda Civic power steering rack defect increases tire failure risk

    Replacement power steering racks in certain 2022-2024 Honda Civic vehicles may have been incorrectly assembled, allowing tires to chafe against the suspension and fail. This affects approximately 264,567 vehicles and increases crash risk.

    Product
    HONDA — HONDA CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24010·2023-10-19

    Thomas & Friends Wooden Railway Troublesome Truck Toys Recalled for Choking and Magnet Ingestion

    Fisher-Price is recalling about 21,000 Thomas & Friends Wooden Railway Troublesome Truck train cars because the magnetic connector piece can detach, posing choking and magnet ingestion hazards.

    Product
    Thomas & Friends Wooden Railway Troublesome Truck & Crates and Thomas & Friends Wooden Railway Troublesome Truck & Paint
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V709000·2023-10-19

    2023 Jaguar I-PACE vehicles recalled for battery fire risk

    Jaguar is recalling 2019-2023 I-PACE vehicles due to battery overheating risk from an incomplete prior repair. Owners must park and charge outside until the software update is installed and for 30 days after.

    Product
    JAGUAR — JAGUAR I-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V701000·2023-10-19

    Alliance RV fifth wheel trailers recalled for loose solar electrical connection

    Alliance RV is recalling 2021-2023 Paradigm and Valor fifth wheel trailers because a wire connector in the solar panel electrical system may loosen and overheat, creating a fire risk.

    Product
    ALLIANCE RV — ALLIANCE RV PARADIGM, VALOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2024·2023-10-18

    Cardinal Health Recalls Surgical Procedure Packs With Recalled Components

    Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.

    Product
    Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2024·2023-10-18

    Knee Tibial Insert Recalled Due to Component Mix-Up in Packaging

    Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2024·2023-10-18

    Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use

    The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.

    Product
    Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2024·2023-10-18

    RoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization

    RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.

    Product
    CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy Balls
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0076-2024·2023-10-18

    Medfusion Syringe Pumps Recalled for Force Sensor Calibration Drift

    The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.

    Product
    Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V700000·2023-10-18

    BMW 750e and multiple 2023-2024 models recalled for steering wheel sensor defect

    BMW is recalling certain 2023-2024 models including the 750e due to a faulty ground connection in the steering wheel electrical system. The defect may render the hands-on detection system inoperative, preventing the emergency stopping assistant from engaging and increasing crash risk.

    Product
    BMW — BMW 740I, I5, I7, I7 M70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2024·2023-10-18

    Medfusion Infusion Pump Plunger Sensor Calibration Drift Recall

    Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.

    Product
    Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2024·2023-10-18

    Multichem control vials break during shipping or thawing due to glass defect

    TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.

    Product
    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0012-2024·2023-10-18

    Maisie Jane's Smooth Almond Butter Recalled for High Aflatoxin Levels

    Maisie Jane's Smooth almond butter is being recalled due to high levels of aflatoxin contamination. Consumers should discard the product or return it for a refund.

    Product
    Maisie Jane's Smooth almond butter, 12 oz glass jar, 6 units per case, shelf stable
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0010-2024·2023-10-18

    Markside Peanut Butter Chocolate Cake Recalled for Undeclared Peanut Allergen

    Fairfield Gourmet Food Corp is recalling Markside Ultimate Peanut Butter Chocolate Cake (LOT #BS23212) due to mislabeled peanut allergen. Consumers with peanut allergies should not consume the product.

    Product
    Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g), plastic package (i.e.) Clamp shell, 8 package per case, Frozen master case (keep refrigerator Retail pack. LOT # BS23212 (Manufactured on July, 31, 2023).
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0077-2024·2023-10-18

    Medfusion Syringe Pump Sensor Calibration Drift May Cause False Alarms

    Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.

    Product
    Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2024·2023-10-18

    BD Pyxis CII Safe ES Software Flaw Disables Controlled Substance Safeguards

    Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.

    Product
    BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2024·2023-10-18

    Glass Vials in Laboratory Control Products Recalled for Breakage Risk

    Multichem P and related laboratory control products are recalled due to defective glass vials that may break during delivery or use, potentially exposing users to biohazardous material.

    Product
    Multichem P, Part Code 08P90-10
    Category
    Medical Device
    Distribution
    Distributed nationwide