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.

5976–6000 of 52958

  • 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
    PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0698-2025·2024-12-25

    ET Tube Holder Recalled Due to Skin Pressure Defect Risk

    Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • 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-0704-2025·2024-12-25

    Fluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing

    GE OEC Elite mobile fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can cause oil leaks and loss of imaging capability. Approximately 100 systems have been affected.

    Product
    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical
    Category
    Medical Device
    Distribution
    45 states
  • 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 (Drugs)·D-0151-2025·2024-12-25

    VCF Contraceptive Pre-filled Applicators Recalled for Out-of-Specification Active Ingredient

    Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.

    Product
    VCF CONTRACEPTIVE PRE-FILLED APPLICATORS — VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0298-2025·2024-12-25

    Frozen Salmon Products Recalled Due to Listeria Risk

    Ocean Group Inc. is recalling multiple frozen salmon products sold in California due to potential Listeria monocytogenes contamination detected in environmental samples at the production facility.

    Product
    SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB SALMON NORWAY 6/7KG FR NOR F LB SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FR F LB SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 7/8KG FR F LB SALM
    Category
    Food
    Distribution
    1 state
  • 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 (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-0697-2025·2024-12-25

    Tracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury

    Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace tracheal tube holder due to adhesive and frame defects that may cause skin pressure injury. The device defect puts pressure on patients' cheekbones and upper lip depending on positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0657-2025·2024-12-25

    Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

    Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

    Product
    Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (Food)·F-0307-2025·2024-12-25

    Griffith Foods Breader Recalled for Potential Metal Contamination

    Griffith Foods Ltd is recalling Item 25293502 Adhesion Breader EX due to potential pieces of metal in the product. The recall affects approximately 25,903 pounds distributed across multiple states.

    Product
    Item 25293502, ADHESION BREADER EX, 50 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0296-2025·2024-12-25

    Candy coated popcorn recalled for undeclared milk allergen

    Yoder's Cashew Crunch candy coated popcorn is recalled due to undeclared milk allergen on package labels. 319 packages were distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Candy coated popcorn packaged in clear plastic with gold label, 7 oz, Yoders Cashew Crunch Corn, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • 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 (Devices)·Z-0687-2025·2024-12-25

    K-Systems G73 Dry Bath Incubator may exceed target temperature

    CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms when this occurs.

    Product
    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at c
    Category
    Medical Device
    Distribution
    14 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 (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 (Drugs)·D-0138-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.

    Product
    M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
    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 (Devices)·Z-0705-2025·2024-12-25

    OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect

    GE OEC Medical Systems is recalling 78 OEC 9900 Elite mobile fluoroscopy systems due to insufficient sealing of X-ray tubes. The defect can result in oil leaks and loss of fluoroscopic imaging capability.

    Product
    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application ma
    Category
    Medical Device
    Distribution
    45 states