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.

12451–12475 of 22165

  • HighFDA (Devices)·Z-1154-2024·2024-02-28

    X-Ray C-Arm System Internal Board Defect Causes Abnormal Images

    Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.

    Product
    The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and proce
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0914-2024·2024-02-28

    Country Corner Dairy Yellow Cheddar Cheese Recall Due to Improper Pasteurization

    Country Corner Dairy is recalling Yellow Cheddar Cheese due to lack of proper pasteurization. The product was distributed in Maryland and Virginia and may pose a food safety risk.

    Product
    Fresh Local , Country Corner Dairy, YELLOW CHEDDAR CHEESE, INGREDIENTS: Pasteurized Milk, Salt , Rennet, Calcium Chloride, Cheese Culture, Color, Contains Milk. Product comes in various sizes, 6 oz. up to 42 lbs. and is in vacuum sealed plastic packaging.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1150-2024·2024-02-28

    Epidural Tray Kits Recalled for Wrong Connector Type

    B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.

    Product
    Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anestheti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0893-2024·2024-02-28

    Bulk Product Recalled for Potential Metal, Wood, and Foreign Material Contamination

    Mennel Milling Company is recalling bulk product 2-00007-0000 due to potential contamination with metal, wood, gasket material, and sifter balls. The product was distributed in Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

    Product
    2-00007-0000 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0886-2024·2024-02-28

    HARD E6 1036 bulk product recalled for foreign material contamination

    Mennel Milling Company is recalling HARD E6 1036 bulk product distributed across six states due to potential contamination with metal, wood, gasket material, and sifter balls. No illnesses have been reported.

    Product
    HARD E6 1036 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0912-2024·2024-02-28

    Country Corner Dairy White Colby Cheese Recalled for Improper Pasteurization

    Country Corner Dairy is recalling WHITE COLBY CHEESE products due to improper pasteurization. The recalled products were distributed to Maryland and Virginia.

    Product
    Fresh Local , Country Corner Dairy, WHITE COLBY CHEESE, INGREDIENTS: Pasteurized Milk, Salt , Rennet, Calcium Chloride, Cheese Culture, Contains Milk. Product comes in various sizes, 6 oz. up to 42 lbs. and is in vacuum sealed plastic packaging.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1171-2024·2024-02-28

    Cardiology imaging software may calculate heart chamber size incorrectly

    Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.

    Product
    Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0895-2024·2024-02-28

    FDA Recalls Bulk Milling Product for Potential Foreign Material

    Mennel Milling Company is recalling its milling product (2-15969-0000) due to potential contamination with metal, wood, gasket material, and sifter balls. The product was distributed across Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

    Product
    2-15969-0000 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0340-2024·2024-02-28

    Prescription injection drug recalled due to temperature excursion during shipment

    Acthar Gel (repository corticotropin injection) is being recalled due to a temperature excursion during shipping from the manufacturer to distributor. Lot #1564-103 should not be dispensed to patients.

    Product
    ACTHAR — ACTHAR (REPOSITORY CORTICOTROPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2024·2024-02-28

    3M Surgical Blade Assembly Recalled for Burn Injury Risk During Use

    3M is recalling the Specialty Blade Assembly (REF 9660) used with 3M Surgical Clippers worldwide due to burn risk if the blade overheats during operation. Approximately 52.8 million units affected across all lot codes.

    Product
    3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0877-2024·2024-02-28

    Mennel Milling White Flour Recalled for Potential Foreign Material

    Mennel Milling Company is recalling white flour delivered as bulk product due to potential contamination with metal, wood, gasket material, and sifter balls. The recall affects approximately 2.6 million pounds distributed across six states.

    Product
    1000000 White Flour UNBL EN MT delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1142-2024·2024-02-28

    Dental cement capsules recalled due to manufacturing defect affecting curing

    IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.

    Product
    IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0883-2024·2024-02-28

    Bagel Flour Recalled Due to Potential Foreign Material Contamination

    Mennel Milling Company is recalling approximately 2.6 million pounds of bagel flour distributed in six states due to potential contamination with metal, wood, gasket material, and sifter balls.

    Product
    BAGEL FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0882-2024·2024-02-28

    Bread Flour Recalled for Potential Metal and Foreign Material Contamination

    Mennel Milling Company is recalling approximately 2.6 million pounds of bread flour due to potential contamination with metal, wood, gasket material, and sifter balls. Affected flour was distributed in six states.

    Product
    43058751 BREAD FLR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0878-2024·2024-02-28

    Donut Cake Flour Recalled for Potential Metal and Foreign Material Contamination

    Mennel Milling Company is recalling donut cake flour products due to potential contamination with metal, wood, gasket material, and sifter balls. The affected product was distributed across six states; no illnesses have been reported.

    Product
    1002560 DONUT CAKE FLR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1178-2024·2024-02-28

    Azurion 7 Medical Imaging System May Lose Power During Procedures

    Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical procedures.

    Product
    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0890-2024·2024-02-28

    Malted Flour Recalled for Potential Foreign Material Contamination

    Mennel Milling Company recalls UNBLE ENR MALTED RM6144 FLOUR for potential foreign material contamination including metal, wood, gasket material, and sifter balls. The recall affects approximately 2.6 million pounds distributed in six states.

    Product
    UNBLE ENR MALTED RM6144 FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0329-2024·2024-02-28

    Meijer Cherry Cough Drops recalled for potential glass and silicone contamination

    Bestco LLC is recalling Meijer Cherry Cough Drops due to potential glass and silicone particulates found during manufacturing quality control inspections. Consumers should stop using the product immediately.

    Product
    Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2024·2024-02-28

    Radiation Oncology Treatment Planning Software VERIQA Calculation Error

    PTW-FREIBURG's VERIQA software (versions 2.0 and 2.1) may incorrectly calculate gamma passing rates when users exclude voxels below a dose threshold, potentially displaying false positive dose evaluation results.

    Product
    Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0901-2024·2024-02-28

    Animal feed recalled for potential foreign material contamination

    Mennel Milling Company recalled PB AP bulk animal feed due to potential contamination with metal, wood, gasket material, and sifter balls. Approximately 2.6 million pounds of affected product was distributed across six states.

    Product
    PB AP delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1172-2024·2024-02-28

    Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis

    FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.

    Product
    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0913-2024·2024-02-28

    Country Corner Dairy Yellow Colby Cheese Recalled for Improper Pasteurization

    Country Corner Dairy is recalling Yellow Colby Cheese distributed in Maryland and Virginia due to insufficient pasteurization during manufacturing.

    Product
    Fresh Local , Country Corner Dairy, YELLOW COLBY CHEESE, INGREDIENTS: Pasteurized Milk, Salt , Rennet, Calcium Chloride, Cheese Culture, Contains Milk. Product comes in various sizes, 6 oz. up to 42 lbs. and is in vacuum sealed plastic packaging.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0331-2024·2024-02-28

    Cough drops recalled for potential glass and silicone contamination

    Bestco LLC is recalling Family Wellness Cherry Cough Drops nationwide due to potential glass and silicone particulates found during manufacturing. Consumers should stop use immediately.

    Product
    Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2024·2024-02-28

    Patterson Procedure Earloop Masks Recalled Due to Non-Validated Production Equipment

    Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.

    Product
    PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
    Category
    Medical Device
    Distribution
    Distributed nationwide