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.

8401–8425 of 52968

  • HighCPSC·24270·2024-06-20

    Yeti Link Expansion Modules and EC8 Cables Recalled for Fire and Burn Hazards

    Goal Zero is recalling about 34,460 Yeti Link Expansion Modules and EC8 Cables because the connections can overheat and melt, posing fire and burn hazards. Two reports of cables melting inside vehicles have been received with minor property damage but no injuries.

    Product
    Yeti Link Expansion Modules and EC8 Cables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24277·2024-06-20

    Head Rush Technologies Recalls TRUBLUE iQ Auto Belay Devices for Fall Hazard

    Head Rush Technologies is recalling TRUBLUE iQ Auto Belay Devices because they can fail to retract, creating a risk of serious injury or death from falls. About 2,200 units were sold online from November 2022 through February 2024.

    Product
    TRUBLUE iQ Auto Belay Devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24279·2024-06-20

    Cedona Natural View Six-Drawer Dressers Recalled for Tip-Over Hazard

    Global Homes USA is recalling about 400 Cedona Natural View six-drawer dressers sold at Rooms To Go for tip-over and entrapment hazards that can injure or kill children if not anchored to a wall.

    Product
    Cedona Natural View six-drawer dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24269·2024-06-20

    StyleCraft Instinct Cordless Hair Clippers Recalled for Fire and Burn Hazards

    StyleCraft is recalling about 50,000 Instinct Professional Vector Motor Cordless Hair Clippers because the lithium-ion battery can overheat, posing fire and burn hazards. Six incidents of battery overheating or fire have been reported, including one minor burn.

    Product
    Instinct Professional Vector Motor Cordless Hair Clippers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24275·2024-06-20

    Babboe Cargo Bicycles Recalled for Frame Cracking and Fall Hazard

    Babboe cargo bicycles manufactured by Babboe B.V. are being recalled because their frames can crack, bend, and break, posing a fall hazard to riders. The recall affects about 300 units sold in the United States through bicycle retailers nationwide between January 2011 and March 2024.

    Product
    Cargo bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24278·2024-06-20

    Orly Lavender Scented Candles Recalled for Fire and Burn Hazards

    CBOCS Distribution Inc. is recalling about 3,600 lavender scented candles in wooden bread bowls sold at Cracker Barrel Old Country Store from November 2023 through May 2024. The candle flames can reach excessive heights and ignite the wooden bowl, posing fire and burn risks.

    Product
    Lavender scented candles in a round wooden bread bowl
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0548-2024·2024-06-19

    FDA Recalls Eye Suspension Medication for Lack of Sterility Assurance

    Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.

    Product
    Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0545-2024·2024-06-19

    Prescription Drug Recall: Phenazopyridine Tablets Contain Wrong Medication

    Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.

    Product
    PHENAZOPYRIDINE HYDROCHLORIDE — PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution

    Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.

    Product
    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2024·2024-06-19

    EsoFLIP 30mm Balloon Dilation Catheter Recalled for Measurement Inaccuracy

    Covidien is recalling EsoFLIP 30mm balloon dilation catheters due to saline conductivity issues that may cause inaccurate esophageal measurements, potentially leading to patient harm.

    Product
    EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1358-2024·2024-06-19

    Jamai Bou Chanachur Snack Mix Recalled for Undeclared Peanuts

    Jamai Bou CHADNI HOT MIX CHANACHUR snack is being recalled because peanuts are present but not declared on the label. This poses a serious risk to consumers with peanut allergies.

    Product
    Jamai Bou CHADNI HOT MIX CHANACHUR, 300 g (10.5 oz) bag, UPC 8 904293 104129, 30 bags per wholesale case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0547-2024·2024-06-19

    Klarity-C Ophthalmic Emulsion Recalled Due to Sterility Assurance Risk

    Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.

    Product
    Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2024·2024-06-19

    CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall

    Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.

    Product
    CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2024·2024-06-19

    VITROS Immunodiagnostic Calibrators Recalled for Potential Accuracy Bias

    Ortho-Clinical Diagnostics is recalling VITROS Anti HBs Calibrators due to potential for positively biased results caused by signal reduction over shelf life. Approximately 481 units were distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2024·2024-06-19

    Cardiac SPECT System Recalled for Defective Service Handle Fastening

    GE Medical Systems is recalling MyoSPECT cardiac imaging systems due to service handles on internal lead covers that could loosen or release, potentially causing the cover to drop and injure service personnel. The recall affects 133 devices distributed worldwide.

    Product
    MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0549-2024·2024-06-19

    Phenazopyridine bottles recalled due to medication mix-up error

    RemedyRepack Inc. is recalling bottles labeled as Phenazopyridine HCl 100mg that actually contain Phenobarbital 16.2mg tablets. Eight bottles were distributed to one medical facility. Patients should not use these medications and must contact their healthcare provider.

    Product
    Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2031-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.

    Product
    Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2024·2024-06-19

    OMTech Desktop Laser Engraver recalled for missing safety interlocks

    Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.

    Product
    OMTech Desktop Laser Engraver
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2024·2024-06-19

    CORI Surgical System Software Error Causes Tracking Array Flickering

    The CORI Starter Kit surgical system may experience display flickering from a software tracking error, potentially causing surgical delays during orthopedic procedures.

    Product
    CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2024·2024-06-19

    Aeos Robotic Digital Microscope recalled for safety mechanism failure

    Aesculap Inc is recalling Aeos Robotic Digital Microscope models with Product Code PV010 due to failure of the integrated safety mechanism. The robotic arm may drop more than 10 cm from its original position after the emergency stop button is pressed.

    Product
    Aeos Robotic Digital Microscope, Product Code: PV010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V456000·2024-06-19

    2024 Tesla Cybertruck front windshield wiper motor failure recall

    Tesla is recalling certain 2024 Cybertruck vehicles due to excessive electrical current that can cause the front windshield wiper motor controller to fail, reducing visibility and increasing crash risk.

    Product
    TESLA — TESLA CYBERTRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2024·2024-06-19

    CODMAN BACTISEAL EVD Catheter Set: Sterile packaging defect recalled

    Integra LifeSciences is recalling 135 CODMAN BACTISEAL EVD Catheter Sets due to defects in sterile packaging that may compromise product sterility.

    Product
    CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2024·2024-06-19

    EVD Catheter Sterile Packaging Defect Recall for Intracranial Drainage

    Integra LifeSciences is recalling CODMAN BACTISEAL EVD catheters due to external packaging seal defects that may compromise sterility. The recall affects 59 units distributed internationally.

    Product
    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2024·2024-06-19

    Stimuplex A Nerve Needles Recalled for Mislabeled DEHP Content

    B Braun Medical Inc is recalling over 1.1 million Stimuplex A nerve block needles labeled as DEHP-free, but the adhesive contains traces of DEHP. The mislabeling poses a risk to users who selected the product specifically to avoid DEHP exposure.

    Product
    Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2024·2024-06-19

    Fresenius AquaA hemodialysis water purification device pressure control malfunction

    Fresenius is recalling 4 hemodialysis water purification devices for pressure control malfunctions. When concentrate pressure exceeds the 19.9 bar limit, the device stops supplying water and halts dialysis treatment.

    Product
    US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
    Category
    Medical Device
    Distribution
    Distributed nationwide