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.

5251–5275 of 52956

  • HighFDA (Devices)·Z-1175-2025·2025-02-26

    3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.

    Product
    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2025·2025-02-26

    Atomoxetine capsules recalled due to elevated N-nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2025·2025-02-26

    Dexcom G6 glucose receiver may fail to deliver high or low alarms

    Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2025·2025-02-26

    Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly

    Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2025·2025-02-26

    Endotracheal Tube Fastener Recalled for Potential Tube Migration Risk

    Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.

    Product
    AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0566-2025·2025-02-26

    Feel Good Foods Three Cheese Mac & Cheese Bites recalled due to metal pieces

    Feel Good Foods Three Cheese Mac & Cheese Bites are being recalled nationwide due to the presence of metal pieces in the frozen product. Metal fragments pose a potential choking or injury hazard.

    Product
    Feel Good Foods; Three Cheese Mac & Cheese Bites; NET WT 8oz (224g); packaged in yellow carton; 9 units per case; Frozen; UPC: 89903900280-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0236-2025·2025-02-26

    Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2025·2025-02-26

    remel Blood Agar EMB Agar Biplate Recalled for Listeria Contamination

    Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.

    Product
    remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2025·2025-02-26

    Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2025·2025-02-26

    RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning

    RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0228-2025·2025-02-26

    Lorazepam tablets recalled due to failed potency and impurity specifications

    The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25E013000·2025-02-24

    Joyson Recalls Side Curtain Air Bag Inflator Due to Detachment Risk

    Joyson is recalling one side curtain air bag inflator because the ignition holder may detach during deployment, creating a projectile hazard.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN:INFLATOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V117000·2025-02-24

    Textron Recalls Cushman and E-Z-GO LSVs for Defective Reflectors

    Textron is recalling 2024-2025 Cushman and E-Z-GO low-speed vehicles because side and rear reflectors do not meet federal safety standards, increasing crash risk.

    Product
    CUSHMAN — CUSHMAN, E-Z-GO TOUR LSV, LIBERTY LSV, HAULER PRO LSV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·006-2025·2025-02-23

    LPK1 Recalls Chicken Caesar Wraps Due to Undeclared Fish Allergen

    LPK1 is recalling ready-to-eat chicken Caesar wraps because the included dressing contains undeclared fish (anchovies). No adverse reactions have been reported.

    Product
    Fresh & Ready Foods LLC — LPK1 Recalls Ready-to-Eat Chicken Caesar Wrap Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·25151·2025-02-20

    ShadesU Roller Window Shades Recalled for Strangulation and Entanglement Hazards

    Shadeks recalls ShadesU Roller Window Shades due to long operating cords that pose strangulation and entanglement hazards to children. About 15,500 units sold on Amazon from June to September 2024 are affected.

    Product
    ShadesU Roller Window Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25143·2025-02-20

    Holosun firearm dot sights recalled for lithium battery ingestion hazard

    Holosun has recalled approximately 9,400 firearm dot sights with accessible lithium coin batteries that pose an ingestion hazard. The products violate federal safety regulations by lacking child-resistant packaging and required warning labels.

    Product
    Holosun Firearm Dot Sights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25145·2025-02-20

    SEJOV Five-Drawer Dressers Recalled for Tip-Over and Entrapment Hazards

    About 900 SEJOV five-drawer dressers sold on Amazon from September 2023 through August 2024 are unstable if not properly anchored to a wall, posing tip-over and entrapment hazards to children. No injuries have been reported.

    Product
    SEJOV Five-Drawer Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25139·2025-02-20

    Nazzaro recalls bowling pin sipper cups due to lead in red tape

    Nazzaro Enterprises is recalling bowling pin sipper cups sold at bowling alleys nationwide because the red tape contains excessive lead. The company is offering refunds.

    Product
    Rebecca's Toys & Prizes Bowling Pin Sipper Cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25144·2025-02-20

    Triumph TF250-X Motorcycles Recalled for Electrical Short Circuits and Unintended Starting

    About 690 Triumph TF250-X motorcycles are recalled due to plastic switch cubes that crack when exposed to brake fluid, creating electrical short circuits that can cause the motorcycle to start unexpectedly. No injuries have been reported.

    Product
    Triumph TF250-X Closed Course Competition Motorcycles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25149·2025-02-20

    Super73 Electric Bicycles Recalled for Brake Failure and Crash Hazard

    Super73 is recalling about 1,400 Model Year 2024 Z Miami SE and Z Adventure Core e-bikes sold April-September 2024. A retaining pin in the disc brake calipers can dislodge, causing brake failure and crash/injury hazards.

    Product
    Model Year 2024 Z Miami SE and Z Adventure Core Electric Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25142·2025-02-20

    Fjorden iPhone Camera Grips Recalled for Coin Battery Ingestion Hazard

    Fjorden iPhone Camera Grips can release their coin batteries if dropped, creating an ingestion hazard for children. Swallowed coin batteries can cause serious internal injuries, chemical burns, and death.

    Product
    Fjorden iPhone Camera Grips
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25147·2025-02-20

    Homebox Blackout Roller Window Shades recalled for strangulation and entanglement hazards

    Homebox Blackout Roller Window Shades sold on Amazon from December 2022 to September 2024 feature long operating cords that pose strangulation and entanglement hazards to children. Consumers should place cords up and away from children.

    Product
    Homebox Blackout Roller Window Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V108000·2025-02-20

    Indian Recalls 2025 Motorcycles Due to Fuel Pump Wire Defect

    Indian Motorcycle is recalling 2025 models due to a wire defect that may cause the fuel pump to fail and the engine to stall.

    Product
    INDIAN — INDIAN PURSUIT, ROADMASTER ELITE, SPRINGFIELD DARK HORSE, CHALLENGER DARK HORSE
    Category
    Vehicle
    Distribution
    Distributed nationwide