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.

9851–9875 of 53039

  • HighFDA (Devices)·Z-1152-2024·2024-02-28

    Philips Azurion X-ray Systems Disk Bay May Fail and Prevent Imaging

    The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2024·2024-02-28

    Philips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk

    Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.

    Product
    Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0908-2024·2024-02-28

    Spice product recalled for undeclared wheat allergen

    Vandevi Compounded Asafoetida spice is recalled due to undeclared wheat. Consumers with wheat allergies should not use this product.

    Product
    Vandevi Compounded Asafoetida 50 gm, 100 gms 200 gm, 500 gm, 1 kg. Packaged in yellow plastic bottles with plastic shrink wrap blue/yellow labels.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1149-2024·2024-02-28

    PERIFIX epidural kits recalled for incompatible filter straw connectors

    B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.

    Product
    Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0885-2024·2024-02-28

    Mennel Milling Company Recalls Dried Grain Product for Foreign Material Contamination

    Mennel Milling Company is recalling approximately 2.6 million pounds of DRIED SOFT 75 ENR 134348 due to potential contamination with metal, wood, gasket material, and sifter balls.

    Product
    DRIED SOFT 75 ENR 134348 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 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-0884-2024·2024-02-28

    Bread Flour Recalled for Potential Foreign Material Contamination

    Mennel Milling Company is recalling bulk bread flour due to potential contamination with metal, wood, gasket material, and sifter balls. The flour was distributed to bakeries and food manufacturers in six states.

    Product
    BREAD FLOUR UNBL ENR 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 (Food)·F-0899-2024·2024-02-28

    Mennel Milling I-52 Patent Flour Recalled for Foreign Material Contamination

    Mennel Milling Company recalled I-52 Patent Flour containing potential foreign material including metal, wood, gasket material, and sifter balls. The flour was distributed in bulk trailers across six states.

    Product
    I-52 PATENT FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 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-1153-2024·2024-02-28

    EndoVive Replacement Button Kits mislabeled with incorrect sizing

    Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.

    Product
    EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
    Category
    Medical Device
    Distribution
    0 states
  • 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-0896-2024·2024-02-28

    Wheat Flour Recalled for Potential Foreign Material Contamination

    Mennel Milling Company is recalling bleached wheat flour due to potential contamination with metal, wood, gasket material, and sifter balls. The product was distributed across six states.

    Product
    BLEACHED WHEAT FLOUR 5600352 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1151-2024·2024-02-28

    Philips Allura Xper X-ray systems disk bay component may malfunction

    Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.

    Product
    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0332-2024·2024-02-28

    Equate Cherry Cough Drops recalled for potential glass and silicone contamination

    Bestco LLC is recalling Equate Cherry Cough Drops nationwide due to potential glass and silicone particulates from manufacturing deviations. Affected products are 30-drop and 160-drop bags expiring December 31, 2026.

    Product
    Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
    Category
    Drug
    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 (Food)·F-0900-2024·2024-02-28

    Bulk Animal Feed Recalled for Potential Foreign Material Contamination

    Mennel Milling Company is recalling non-human consumption feed products due to potential contamination with metal, wood, and gasket material. Approximately 2.6 million pounds were distributed across six states.

    Product
    NON-HUMAN CONSUMPTION delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0881-2024·2024-02-28

    Bulk animal feed product recalled for potential foreign material contamination

    Mennel Milling Company is recalling 2ND CLEAR 1051664, a bulk animal feed product, due to potential contamination with metal, wood, gasket material, and sifter balls. Affected products were distributed in Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

    Product
    2ND CLEAR 1051664 delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0880-2024·2024-02-28

    Flour recalled for potential metal and foreign material contamination

    Mennel Milling Company is recalling flour products due to potential contamination with metal, wood, gasket material, and sifter balls. Affected product was distributed in Kentucky, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

    Product
    160919 FLR BLE WINTER delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • 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 (Food)·F-0904-2024·2024-02-28

    Bulk Fortune Cookies Recalled for Undeclared Wheat and Soy

    New World Company is recalling bulk cases of Fortune cookies distributed in California due to undeclared wheat and soy allergens that pose a risk to consumers with these allergies.

    Product
    Bulk case of Fortune cookies, labeled as 6 lb (1.3 lb per bag/ 4 bags per case)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1147-2024·2024-02-28

    Henry Schein Criterion Anti-Fog Earloop Masks Recalled for Equipment Validation Issue

    AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.

    Product
    HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0892-2024·2024-02-28

    Flour Product Recall Due to Foreign Material Contamination

    Mennel Milling Company is recalling 2.6 million pounds of bulk AP flour that may contain metal, wood, gasket material, and sifter balls. The flour was distributed in six states and should not be used.

    Product
    01050 KA AP FLOUR delivered as bulk product in approximately 50,000 lbs trailers
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1156-2024·2024-02-28

    Philips Allura Xper X-ray System Memory Modules May Stop Functioning

    Philips Allura Xper fluoroscopic X-ray systems may experience memory module failures that cause the system to stop functioning and prevent imaging. This malfunction could delay critical medical procedures.

    Product
    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027;
    Category
    Medical Device
    Distribution
    Distributed nationwide