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.

5201–5225 of 52956

  • HighCPSC·25704·2025-02-27

    Wayfair Recalls Style Life Eleven Baby Loungers for Suffocation and Fall Hazards

    Wayfair recalls about 1,555 Style Life Eleven baby loungers due to suffocation, fall, and entrapment hazards that violate federal infant sleep safety standards. Stop using them and contact Wayfair for a refund.

    Product
    Style Life Eleven Baby Loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25161·2025-02-27

    P.J. Salvage Children's Pajama Sets and Robes Recalled for Flammability Violation

    P.J. Salvage recalled approximately 9,400 children's pajama sets and robes sold at Nordstrom Rack because they violate federal flammability regulations, posing a risk of burn injuries to children. No injuries have been reported.

    Product
    P.J. Salvage Pajama Sets and Robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25166·2025-02-27

    Costway recalls Babyjoy high chairs due to suffocation and entrapment hazards

    Costway is recalling about 4,400 Babyjoy high chairs due to suffocation and entrapment hazards. The chairs were designed or marketed for infant sleep with excessive incline and have unsafe gaps where children can become trapped.

    Product
    Babyjoy High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25156·2025-02-27

    Canyon Speedmax CF Triathlon Bicycles Recalled for Fork Cracking Hazard

    Canyon Bicycles USA recalls about 1,400 Speedmax CF triathlon bicycles due to fork steerer tubes that can crack or break, creating a fall hazard. The company is offering free repairs at authorized service centers.

    Product
    Canyon Speedmax CF Triathlon Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V120000·2025-02-27

    Volkswagen and Audi electric vehicles may not display gear position indicator

    Volkswagen is recalling certain 2021-2023 ID.4 and 2022-2023 Audi Q4 e-Tron vehicles because the instrument panel may not properly display the transmission gear lever indicator, failing FMVSS 102.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI ID.4, Q4 E-TRON, Q4 SPORTBACK E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V122000·2025-02-27

    Orange EV Recalls HUSK-E Trucks Due to Incorrect Weight Rating Placard

    Orange EV is recalling 2023-2024 HUSK-E XP terminal trucks because the rear weight rating placard is incorrect and tires may be inadequate, increasing crash risk.

    Product
    ORANGE EV — ORANGE EV HUSK-E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2025·2025-02-26

    Medical device recall: RayStation radiation therapy software dose calculation inconsistency

    RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2025·2025-02-26

    RayStation Radiation Therapy Software Recalled for Dose Calculation Inconsistency

    RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty computational defect

    RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2025·2025-02-26

    Augustine HotDog return electrode connector cables electrode contact error recall

    Augustine Temperature Management is recalling HotDog return electrode accessory connector cables (Model A136) used with warming blankets and mattresses. Users reported error M-0B-125 indicating improper neutral electrode contact.

    Product
    Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0241-2025·2025-02-26

    Atomoxetine 40 mg Capsules Recalled for N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals is recalling 233,040 bottles of Atomoxetine 40 mg capsules nationwide due to N-Nitroso impurity above FDA safety limits. Patients should check their medication bottles and contact their healthcare provider.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0565-2025·2025-02-26

    THREE RIVERS Tutti-Frutti Candy Recalled for Undeclared Yellow Dyes

    THREE RIVERS brand Tutti-Frutti candy contains undeclared FD&C Yellow 5 and Yellow 6 dyes that were not listed on the label. Consumers allergic or sensitive to these colorants should not consume the product.

    Product
    THREE RIVERS brand TUTTI-FRUTTI; INGREDIENTS Papaya Cubes, Sugar, Citric Acid (E-330), Potassium Sorbate (E-202), FD&C Red #40, FD&C Blue #1, Curcumine #E-100, Annatto #E-160b; Imported & Distributed by SHATA TRADERS; Net Weight - 250 g, 8.81 OZ, 0.55 LBS; UPC: 7 93283 75373 1
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0235-2025·2025-02-26

    Atomoxetine Capsules Recalled Due to Excess N-Nitroso Impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to the presence of N-Nitroso Atomoxetine impurity above FDA recommended limits. The nationwide recall affects 80,160 bottles.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2025·2025-02-26

    Radiation Therapy Planning System Density Calculation Inconsistency in RayStation

    RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0237-2025·2025-02-26

    Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 39,168 bottles of Atomoxetine 100 mg capsules nationwide due to manufacturing deviations that resulted in N-Nitroso impurity exceeding FDA recommended limits. No illnesses have been reported.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2025·2025-02-26

    Patient Warming Mattress Connector Cable Intermittent Connection Defect

    Augustine Temperature Management is recalling Hot Dog Patient Warming Mattresses due to connector cable defects that may cause intermittent electrical connection after extended use, potentially affecting the device's heating function.

    Product
    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0242-2025·2025-02-26

    Atomoxetine Capsules Recalled for Manufacturing Impurity Above Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2025·2025-02-26

    Medline Intubation Kits Recalled Due to Reduced Skin Barrier Wear

    Medline is recalling 70 intubation convenience kits distributed in California and New York due to skin barrier components with reduced wear time that may lose effectiveness sooner than intended.

    Product
    Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0233-2025·2025-02-26

    Prescription Atomoxetine capsules recalled for N-Nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0227-2025·2025-02-26

    Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications

    The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    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 (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 (Devices)·Z-1188-2025·2025-02-26

    Medical Device RayStation Dosage Calculation Inconsistency in Radiation Therapy Planning

    RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 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
  • 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