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.

13501–13525 of 22165

  • HighFDA (Devices)·Z-0306-2024·2023-11-22

    Philips Spectral CT on Rails Software Crash During Fluoroscopy Operations

    Philips is recalling the Spectral CT on Rails (Model 728334, Software Version 5.1.0) due to a software crash that occurs when CCT Fluoroscopy mode and foot pedal are activated simultaneously. The crash requires system restart.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2024·2023-11-22

    DOP Instant Hand Sanitizer Recalled for Potency Defects in Puerto Rico

    Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.

    Product
    DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0305-2024·2023-11-22

    Defibrillator battery pins may loosen, affecting power

    Physio-Control LIFEPAK 15 defibrillators (serial numbers 48433670 and 48744028) may experience battery pin loosening, potentially causing power issues. Two units were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24031·2023-11-22

    Lenovo USB-C Laptop Power Banks Recalled for Fire Hazard

    Lenovo is recalling about 2,850 USB-C laptop power banks because internal screws can loosen, causing a short circuit and lithium-ion battery overheating. One fire with minimal property damage has been reported.

    Product
    Lenovo USB-C Laptop Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.

    Product
    LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0417-2024·2023-11-22

    Hemp Oil Gummies Recalled Due to Undeclared Sunflower Butter Allergen

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because sunflower butter sub-ingredients were not declared on the label. Consumers with sunflower allergies may experience allergic reactions.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Pomegranate, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0105-2024·2023-11-22

    Equate Hand Sanitizer recalled for potency non-compliance in Puerto Rico

    Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.

    Product
    Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0416-2024·2023-11-22

    Hemp Oil Gummies Recalled for Undeclared Sunflower Butter Sub-Ingredients

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because the sub-ingredients of sunflower butter were not declared on the label. The affected packages were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Peach, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0299-2024·2023-11-22

    LIFEPAK 15 defibrillator recalled for potential battery power loss

    Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

    Product
    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2024·2023-11-22

    Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination

    Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.

    Product
    LYFO-DISK, P. venetum, Catalog number 0794L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2024·2023-11-22

    Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions

    Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.

    Product
    Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2024·2023-11-22

    Ocean Chest Drains Recalled for Inadequate Assembly Instructions

    Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.

    Product
    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24714·2023-11-16

    LAOION Children's Cups Recalled for Lead Content and Lid Hazards

    LAOION children's cups sold on Amazon contain lead in solder on the cup bottom and have lids that can crack, creating choking and laceration risks. About 200 units were sold from March to May 2023.

    Product
    LAOION Children's Cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24026·2023-11-16

    Tractor Supply Red Shed Hammock Swing Chairs Recalled Due to Fall Hazard

    Tractor Supply is recalling about 7,500 Red Shed® Hammock Swing Chairs because the plastic buckle supporting the back can break while someone is seated, causing a fall. The company has received 13 reports of buckle or stitching failures, including three falls.

    Product
    Red Shed® Hammock Swing Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24715·2023-11-16

    Target Recalls Hearth & Hand Toy Mushroom Peg Sorters Due to Choking Hazard

    Target is recalling about 1,850 units of its 13-Piece Toy Mushroom Peg Sorters because the mushroom stems can detach, posing a choking hazard to young children. No injuries have been reported.

    Product
    13-Piece Toy Mushroom Peg Sorters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2024·2023-11-15

    Monitron II Waveform Analyzer Screen Freeze Defect in Ventilator Models

    Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.

    Product
    Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0231-2024·2023-11-15

    Breg Folding Walkers With Wheels Recalled for Misaligned Wheels

    Breg Inc is recalling 11,193 folding walkers with misaligned wheels that do not meet product specifications. The defect could affect stability and increase fall risk.

    Product
    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0249-2024·2023-11-15

    Stryker Bipolar Forceps Recalled for Incorrect Expiration-Date Labeling

    Stryker Corporation is recalling 2,321 Disposable Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. Products labeled with 54-month shelf life actually have a 36-month shelf life.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2024·2023-11-15

    Temporary Dental Fillings Recalled Due to Improper Storage Conditions

    Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.

    Product
    DENTEMP ONE STEP .077OZ, SKU 902139
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0133-2024·2023-11-15

    Medical administration set for radiation therapy recalled due to leakage risk

    B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

    Product
    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2024·2023-11-15

    Stryker disposable surgical forceps recalled for incorrect expiration date labeling

    Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide