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.

8901–8925 of 22113

  • HighFDA (Food)·F-0294-2025·2024-12-25

    Yoder's Cashew Crunch hard candy recalled for undeclared milk allergen

    Yoder's Cashew Crunch hard candy contains undeclared milk allergen. Affected packages were distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, 14oz, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0692-2025·2024-12-25

    K-Systems Incubator Device Recall: Temperature May Exceed Desired Setting

    CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.

    Product
    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g.,
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0710-2025·2024-12-25

    Medical imaging software recall for incorrect DICOM orientation labels

    Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.

    Product
    mint Lesion, Software Versions: 3.10.0 and 3.10.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2025·2024-12-25

    K-Systems G85 Mini Incubator May Exceed Desired Temperature

    CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.

    Product
    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0709-2025·2024-12-25

    Medical Imaging Software Recall: mint Lesion Orientation Display Malfunction

    Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in the US and internationally.

    Product
    mint Lesion, Software Versions: 3.9.0 through 3.9.5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0374-2025·2024-12-25

    Cucumber Products Recalled Due to Potential Salmonella Contamination

    Indianapolis Fruit Company is recalling 288 cases of cucumber products distributed to Indiana, Kentucky, Ohio, and Pennsylvania due to potential salmonella contamination.

    Product
    Cucumbers Slices 1/2 Cup, 100 cups per case, Product Code CUCS100, Item Number - 14705 Cucumbers Diced 1" Peeled 5 lb. tray, 2 trays per case, Product Code CUDN45L, Item Number - 9975 Cucumbers Slices 2 oz., 100 per case, Product Code CUS100, Item Number - 9816 Cucumbers Slices
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0285-2025·2024-12-25

    Impossible Spicy Ground Sausage Recalled for Potential Metal Contamination

    Impossible Foods is recalling Impossible Spicy Ground Sausage due to potential metal pieces in the product. The recall affects 32,536 cases distributed nationwide with use-by dates between June 28, 2025 and January 28, 2026.

    Product
    Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0311-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps recalled for possible metal contamination

    Rise Baking Company is recalling L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps sold at Aldi stores in five states due to potential metal contamination. Affected products carry specific Julian date codes from 24 302 to 24 311.

    Product
    L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0292-2025·2024-12-25

    Whole Foods Organic Carrots & Celery Recalled Due to E. coli O121:H19 Contamination Risk

    F&S Fresh Foods is recalling Whole Foods Market Organic Carrots & Celery due to potential E. coli O121:H19 contamination. The affected products were distributed in AZ, CA, HI, ID, and NV.

    Product
    WHOLE FOODS MARKET, Organic Carrots & Celery, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0686-2025·2024-12-25

    Philips Access Point Software Issue Risks Patient Data Loss

    Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.

    Product
    Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0293-2025·2024-12-25

    Yoder's Cashew Crunch hard candy recalled for undeclared milk allergen

    Yoder's Cashew Crunch hard candy is being recalled due to undeclared milk allergen on the label. The product was distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, Wt. 7oz, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0140-2025·2024-12-25

    Dental City Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Dental City Topical Anesthetic Gel (Benzocaine 20%) is recalled because the product was released and distributed despite failing quality inspection. Scratches were found in the mixing vessel during routine inspection.

    Product
    Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0306-2025·2024-12-25

    Griffith Foods Italian Style Herb Powder Recalled for Metal Contamination

    Griffith Foods has recalled Item 79588401 (Italian Style Herb Powder) in 55 lb bags due to potential metal pieces. Affected lots 577773 and 577774 were distributed to IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 79588401, ITAL STY PD HERB REDUCED EX, 55 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0312-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps Recalled for Metal Contamination

    L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps are being recalled due to potential metal contamination. Products were distributed in CT, KS, MN, OH, and TX.

    Product
    L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271355. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0693-2025·2024-12-25

    Bronchoscopic system may lose power due to defective component

    A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.

    Product
    Galaxy System (GAL-001)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0702-2025·2024-12-25

    Hillrom Temperature Management Controller Power-On Self-Test Error Code Update

    Augustine Temperature Management recalled Hillrom Temperature Management Controllers (Models WC71, WC77, and MP 2083516) due to power-on self-test error code EA POST. No injuries or illnesses reported.

    Product
    Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0304-2025·2024-12-25

    Spicy Breading Product Recalled for Potential Metal Contamination

    GRIFFITH FOODS LTD has recalled 50-pound bags of Spicy Breading Export (LOT 575830) due to potential metal contamination. Affected product was distributed to IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 42081001, 104023600 SPICY BREADING EXPORT, 50 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0707-2025·2024-12-25

    Duravent Silicone Ventilation Tubes recalled for product substitution error

    Olympus is recalling 984 Duravent Silicone Ventilation Tubes (Model 240075) due to the potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended product.

    Product
    Duravent Silicone Ventilation Tube. Model Number: 240075.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0690-2025·2024-12-25

    K-Systems T47 Warming Plate May Exceed Set Temperatures

    CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0139-2025·2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0297-2025·2024-12-25

    Bulk Candy Coated Popcorn Recalled for Undeclared Milk Allergen

    Yoder's Cashew Crunch Corn, unlabeled bulk candy coated popcorn, is being recalled because milk allergen is not declared. The product was distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Yoder's Cashew Crunch Corn, bulk candy coated popcorn packaged in clear plastic without label.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0696-2025·2024-12-25

    ET Tube Holder Recalled for Risk of Facial Skin Injury

    Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0706-2025·2024-12-25

    GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing

    GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.

    Product
    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscop
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Drugs)·D-0153-2025·2024-12-25

    OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

    REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    REGENER-EYES — REGENER-EYES (REGENER-EYES)
    Category
    Drug
    Distribution
    Distributed nationwide