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.

10426–10450 of 22146

  • HighFDA (Food)·F-1730-2024·2024-08-21

    Pariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination

    Pariva LLC is recalling Pariva Marinated Labneh Bites Mild Tandoori due to potential mold contamination. Affected products were distributed in Massachusetts, Maine, New Hampshire, Rhode Island, New York, New Jersey, and Connecticut.

    Product
    Pariva Marinated Labneh Bites Mild Tandoori; NET WT 8 OZ (225g); INGREDIENTS: YOGURT (CULTURED PASTEURIZED GRADE A MILK & CREAM, SKIM MILK, WHEY PROTEIN CONCENTRATE, SALT AND PECTIN), *SUNFLOWER OIL, *EXTRA VIRGIN OLIVE OIL, SPICES; CONTAINS: MILK, Distributed by, Mayur, LLC, 196
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2569-2024·2024-08-21

    Merit Medical pericardiocentesis kits recalled for syringe defects

    Merit Medical convenience kits containing plastic syringes have been recalled nationwide. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24344·2024-08-15

    IKEA VARMFRONT Power Banks Recalled Due to Fire Hazard

    IKEA is recalling approximately 1,600 VARMFRONT Power Banks (models E2037 and E2038) because the devices can overheat and pose a fire hazard. No injuries have been reported in the United States.

    Product
    VARMFRONT Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24341·2024-08-15

    ALDI Recalls Ambiano Single Serve Coffee Makers for Burn Hazard

    ALDI is recalling about 28,000 Ambiano Single Serve Coffee Makers because the machines can expel hot water from the top, causing burns. ALDI has received 25 reports of this defect, including three burn injuries.

    Product
    Ambiano Single Serve Coffee Makers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24340·2024-08-15

    Mamibaby and Cosy Nation Baby Loungers Recalled for Suffocation and Fall Hazards

    About 32,270 Mamibaby and Cosy Nation baby loungers sold on Amazon.com from June 2023 through June 2024 are being recalled because they violate federal infant sleep product regulations and pose suffocation, fall, and entrapment hazards to infants.

    Product
    Mamibaby and Cosy Nation Baby Loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24342·2024-08-15

    Trader Joe's Mango Tangerine Scented Candles Recalled for Fire Hazard

    Trader Joe's recalls 653,000 Mango Tangerine Scented Candles due to fire hazard—flame can spread from wick to wax. Fourteen incidents reported, including minor burns and property damage.

    Product
    Mango Tangerine Scented Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24745·2024-08-15

    BJ's Warehouse Recalls Berkley Jensen Gazebos for Roof Panel Hazard

    BJ's Wholesale Club is recalling about 32,500 Berkley Jensen gazebos because roof panels can dislodge in high winds, causing injury. The company has reported 137 incidents, including one minor injury.

    Product
    Berkley Jensen Gazebos
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24345·2024-08-15

    DeWALT Battery Walk-Behind Mowers Recalled for Laceration Hazard

    Stanley Black & Decker is recalling about 46,200 DeWALT Battery walk-behind mowers because water entering the handle support can cause the mower to fail to shut off or start without a key, posing a laceration risk.

    Product
    DeWALT Battery Push walk-behind mowers and DeWALT Battery Self-Propelled walk-behind mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1718-2024·2024-08-14

    Panaderia Guatemex Besos Bakery Products Recalled for Undeclared Soy

    Panaderia Guatemex is recalling 170 bags of Besos packaged bakery products distributed in Georgia, Kentucky, and Tennessee because they contain undeclared soy, a known allergen that poses a risk to consumers with soy allergies.

    Product
    Panaderia Guatemex - Besos packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2518-2024·2024-08-14

    Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process

    American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.

    Product
    American Contract Systems Gyn Laparoscopy convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2024·2024-08-14

    Philips IntelliVue Patient Monitors Shipped with Missing Monitoring Capabilities

    Philips IntelliVue patient monitors shipped or updated with software that removes monitoring capabilities, potentially delaying or resulting in incorrect treatment.

    Product
    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2024·2024-08-14

    Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2024·2024-08-14

    MRI System Software Error Can Overheat Patient Implants

    GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.

    Product
    SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1657-2024·2024-08-14

    Palmer Patriotic Snack Mix Recalled for Potential Salmonella Contamination

    Palmer & Company is recalling Palmer Patriotic Snack Mix (13 oz, Best By 1/19/25–2/1/25) due to potential Salmonella contamination. The product was distributed nationwide in the United States and Canada.

    Product
    Palmer Patriotic Snack Mix, A Seasonal Mix of Sweet & Salty Favorites, Net Wt. 13 oz., UPC 77232 37061, 12/13oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2024·2024-08-14

    BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units

    CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2024·2024-08-14

    Philips IntelliVue Patient Monitors with disabled monitoring software options

    Philips IntelliVue Patient Monitors (MX400/450/500/550) with software versions L.x or M.x lack required monitoring capabilities due to removed software entitlements. The missing features could lead to incorrect or delayed patient treatment.

    Product
    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2024·2024-08-14

    Surgical Convenience Kits Recalled for Potential Sterilization Failure

    American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.

    Product
    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1723-2024·2024-08-14

    Panaderia Guatemex Curenitos Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling 170 bags of Curenitos due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Curenitos packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1716-2024·2024-08-14

    Panaderia Guatemex Corona Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling Corona brand bread packaged in plastic bags due to undeclared soy allergen. The affected product was distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Corona packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1725-2024·2024-08-14

    Concha Mexicana Pastries Recalled Due to Undeclared Soy Allergen

    Panaderia Guatemex is recalling Concha Mexicana pastries due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Concha Mexicana packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2484-2024·2024-08-14

    SIGNA MAGNUS MRI Software Can Overheat Implanted Devices

    GE Medical Systems recalled SIGNA MAGNUS MRI systems with software versions MR29.1 or RX29.1. Under specific imaging conditions in Low SAR Mode, the system may exceed safe radiofrequency power limits and cause implanted medical devices to overheat.

    Product
    SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2532-2024·2024-08-14

    FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results

    Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.

    Product
    (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2480-2024·2024-08-14

    MRI System Software Issue Can Overheat Implanted Medical Devices

    GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.

    Product
    SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2534-2024·2024-08-14

    Philips Azurion X-ray System: Potential Loss of Imaging Functionality

    The Philips Azurion Interventional Fluoroscopic X-ray System may lose imaging functionality or experience longer restart times. The FDA is recalling approximately 3,011 units of this device worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, car
    Category
    Medical Device
    Distribution
    Distributed nationwide