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.

5426–5450 of 52957

  • HighFDA (Food)·F-0506-2025·2025-02-12

    FGF Fluff Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of item 8201870 Fluff Donuts due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024, and distributed nationwide in the US and Canada.

    Product
    item 8201870 GEN BAR FLUFF DONUT ZGT PFD 78x3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2025·2025-02-12

    VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure

    The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.

    Product
    SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1115-2025·2025-02-12

    Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors

    Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0473-2025·2025-02-12

    Apple fritter recall due to potential Listeria monocytogenes contamination

    FGF LLC is recalling apple fritters nationwide due to potential Listeria monocytogenes contamination. All product produced on or before December 13, 2024 is affected.

    Product
    item 8201805 APPLE FRITTER 60x2.5 OZ, NET WT 8.44 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0522-2025·2025-02-12

    French Cruller Recall Due to Listeria Contamination Risk

    FGF, LLC is recalling French Crullers (item 8201921) distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.

    Product
    item 8201921 FRENCH CRULLER PFD 72x1.6 OZ, NET WT 6.48 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0499-2025·2025-02-12

    FGF Sour Cream Cake Donuts Recalled Due to Listeria Contamination Risk

    FGF's Just Baked Sour Cream Cake Donuts are being recalled nationwide due to potential Listeria monocytogenes contamination. Approximately 2 million cases produced on or before December 13, 2024 are affected.

    Product
    item 8201860 JUST BAKED SOUR CREAM CAKE DONUTS 120x2.5 OZ, NET WT 18.75 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0475-2025·2025-02-12

    Bavarian Filled Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Bavarian Filled Donuts distributed nationwide due to potential listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    item 8201807 BAVARIAN FILLED DONUT 78x2.75OZ, NET WT 12.07 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0477-2025·2025-02-12

    FGF Plain Cake Donuts Recalled Due to Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of plain cake donuts distributed nationwide in the US and Canada due to potential contamination with Listeria monocytogenes. No illnesses have been reported.

    Product
    item 8201809 PLAIN CAKE DONUT 108x2.25 OZ, NET WT 13.67 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0459-2025·2025-02-12

    Monkey Spit Atomic Mop BBQ Sauce recalled for undeclared milk allergen

    Monkey Spit Atomic Mop BBQ Sauce contains undeclared milk from butter, posing a risk to consumers with milk allergies. Affected bottles were distributed primarily to local markets and nationwide through online sales.

    Product
    Monkey Spit "Atomic Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Manufactured by Smith House MFG. 146-A S. Thompson Ave. Nipomo, CA 93444 (805) 619-7959; UPC#8 54540 00212 9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·25V082000·2025-02-12

    Volkswagen Tiguan camera control units may error at vehicle startup

    Volkswagen is recalling certain Tiguan, Arteon and Audi Q3 vehicles because a camera control unit error at startup may prevent the rearview image displaying.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI TIGUAN, ARTEON, Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02122025-01·2025-02-12

    Frozen Ready-to-Eat Meat and Poultry Pasties Recalled for Undeclared Egg Allergen

    USDA FSIS issued a public health alert for The Pasty Oven frozen pasties due to an undeclared egg allergen. No illnesses have been reported.

    Product
    The Pasty Oven, Inc. — FSIS Issues Public Health Alert for Frozen Ready-To-Eat Meat and Poultry Pasties Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0221-2025·2025-02-12

    Potassium Chloride Tablets Recalled for Failed Dissolution Specifications

    The FDA is recalling Potassium Chloride Extended-Release Tablets (10 mEq) distributed nationwide because they failed dissolution tests. This could affect how the medication is released in the body.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0471-2025·2025-02-12

    Chocolate Donut Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling chocolate-coated donut rings nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected. No illnesses have been reported.

    Product
    item 8201780 GEN CHOC CK DONUT RINGS PFD 90x2.5OZ, NET WT12.66LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0220-2025·2025-02-12

    HydrALAZINE Hydrochloride tablets recalled for failed purity and degradation specifications

    SKY PACKAGING is recalling HydrALAZINE Hydrochloride 50mg tablets nationwide due to failed impurities and degradation specifications. Four affected lot numbers have expiration dates from April 2025 to February 2026.

    Product
    HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0480-2025·2025-02-12

    French Crullers Recalled Nationwide for Potential Listeria Contamination

    FGF, LLC is recalling French Crullers sold nationwide and in Canada due to potential Listeria monocytogenes contamination. All product with expiration dates from 12/13/24 and earlier is affected.

    Product
    item 8201812 FRENCH CRULLERS 72x 1.6 OZ, NET WT 6.48 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0509-2025·2025-02-12

    Pumpkin-shaped donuts recalled for potential Listeria contamination

    FGF, LLC is recalling pumpkin-shaped donuts distributed nationwide due to potential contamination with Listeria monocytogenes. Consumers should not consume the product.

    Product
    item 8201876 PMPKN SHAPE DONUT ZGT PFD 84x1.75OZ, NET WT 8.27 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0517-2025·2025-02-12

    FGF Chocolate Cake Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of JUST BAKED Chocolate Cake Rings distributed nationwide in the US and Canada due to potential Listeria monocytogenes contamination.

    Product
    item 8201904 JUST BAKED CHOCOLATE CAKE RINGS ARTIFICIALLY FLAVORED 144x2.5OZ, NET WT 22.5 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2025·2025-02-12

    X-Ray imaging systems may allow radiation exposure beyond safety limits

    GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.

    Product
    Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0524-2025·2025-02-12

    Donut Product Recalled for Potential Listeria Monocytogenes

    FGF, LLC is recalling approximately 2 million cases of its BAV CRM BAR DONUT product nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume the product and should dispose of it or return it to the retailer.

    Product
    item 8201923 BAV CRM BAR DONUT PFD 78 X 3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2025·2025-02-12

    Philips AlluraXper FD20 operating room surgical table finger entrapment risk

    Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.

    Product
    AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0485-2025·2025-02-12

    Apple-Filled Paczki from FGF, LLC recalled for potential Listeria contamination

    FGF, LLC is recalling apple-filled paczki sold nationwide due to potential contamination with Listeria monocytogenes. Affected units were produced on or before December 13, 2024.

    Product
    item 8201817 APPLE FILLED PACZKI 66x4 OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2025·2025-02-12

    IntelliBridge EC10 Module may fail to alarm on ventilator disconnection

    The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.

    Product
    IntelliBridge EC10 Module. Model Number: 865115
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0501-2025·2025-02-12

    FGF LLC Recalls Just Baked Coffee Rolls Over Listeria Contamination Risk

    FGF LLC is recalling 2,017,614 cases of Just Baked Coffee Rolls (78 x 3oz packages) due to potential Listeria monocytogenes contamination. The affected product was produced on or before 12/13/24 and distributed nationwide in the US and Canada.

    Product
    item 8201864 JUST BAKED COFFEE ROLLS 78x3OZ, NET WT 14.62 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0502-2025·2025-02-12

    Just Baked Apple Fritters Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling Just Baked Apple Fritters nationwide due to potential Listeria monocytogenes contamination. Consumers should discard affected products.

    Product
    item 8201865 JUST BAKED APPLE FRITTERS 72x3OZ, NET WT 13.50 LB
    Category
    Food
    Distribution
    Distributed nationwide