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.

8251–8275 of 22104

  • HighFDA (Devices)·Z-1077-2025·2025-02-12

    Philips AD7 and AD7X patient tables recalled due to finger entrapment risk

    Philips has recalled the AD7 and AD7X patient tables used in medical imaging systems because fingers can become entrapped between the tabletop and guiding rails during manual repositioning, potentially causing injury.

    Product
    Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0217-2025·2025-02-12

    Carvedilol 25 mg tablets recalled due to N-nitroso impurity above limit

    RemedyRepack Inc. is recalling certain Carvedilol 25 mg tablets because testing found N-nitroso Carvedilol Impurity-1 exceeding FDA's acceptable limit due to manufacturing process deviations.

    Product
    Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0458-2025·2025-02-12

    Monkey Spit BBQ Sauce recalled due to undeclared soy allergen

    Monkey Spit 'Swamp Mop' BBQ Sauce is being recalled because it contains an undeclared soy allergen in a sub-ingredient. The product was distributed through local markets and online sales nationwide.

    Product
    Monkey Spit "Swamp Mop" BBQ Sauce, 12 fl oz (355ml) glass bottle, 12 bottles/case; Refrigerate after opening; Monkey Spit, LLC, Tepusquet Cyn Santa Maria, CA 93454; Manufactured by Smith House MFG. 146-A S. Thompson Ave. Nipomo, CA 93444 (805) 619.7959 UPC#8 54540 00230 3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0515-2025·2025-02-12

    Apple Fritter Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling apple fritter donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    item 8201900 APPLE FRITTER DONUT ZGT PFD 54x3OZ, NET WT 9.11 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0486-2025·2025-02-12

    FGF Yeast Ring Products Recalled for Potential Listeria Contamination

    FGF, LLC has recalled Just Baked Yeast Ring products due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed nationwide in the United States and Canada.

    Product
    item 8201834 JUST BAKED YEAST RING 120x1.88 OZ, NET WT 14.10 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2025·2025-02-12

    VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect

    LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.

    Product
    SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-0507-2025·2025-02-12

    ESL Cinnamon Fries Recalled for Potential Listeria Contamination

    ESL Cinnamon Fries (item 8201871) produced on December 13, 2024 and prior are being recalled due to potential contamination with Listeria monocytogenes. Approximately 2 million cases were distributed nationwide in the US and Canada.

    Product
    item 8201871 ESL CINNAMON FRIES 60x3OZ, NET WT 10.13 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0472-2025·2025-02-12

    FGF Yeast Ring Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of yeast ring donuts nationwide due to potential Listeria monocytogenes contamination. The affected product was produced on or before December 13, 2024.

    Product
    item 8201804 Yeast Ring Donut 108x2.15OZ, NET WT 13.06 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-0484-2025·2025-02-12

    Cheese Paczki Recalled Due to Potential Listeria Monocytogenes Contamination

    FGF, LLC is recalling cheese paczki products nationwide due to potential contamination with listeria monocytogenes. Affected products were produced on or before December 13, 2024.

    Product
    item 8201816 NATURALLY AND ARTIFICIALLY FLAVORED CHEESE PACZKI 66x4OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0508-2025·2025-02-12

    FGF LLC Frozen Donuts Recalled for Listeria Contamination Risk

    FGF, LLC is recalling BAV CRM BISMARK DONUT frozen donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not eat the product.

    Product
    item 8201872 BAV CRM BISMARK DONUT PFD 60x3.85OZ, NET WT 12.99 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0523-2025·2025-02-12

    Flavored Raspberry Bismark Pastries Recalled for Potential Listeria Contamination

    FGF, LLC is recalling flavored raspberry Bismark pastries over potential contamination with Listeria monocytogenes. The recall affects product produced on or before December 13, 2024.

    Product
    item 8201922 FLAVORED RASPBERRY BISMARK PFD 3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2025·2025-02-12

    Patient Monitor May Fail to Alert When Ventilator Disconnects

    Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.

    Product
    IntelliVue Patient Monitor MX450. Model Number: 866062
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0494-2025·2025-02-12

    Frozen donuts recalled nationwide for potential listeria contamination

    FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Affected products were produced on or before December 13, 2024.

    Product
    item 8201845 GEN RG HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2025·2025-02-12

    Philips AD7 and AD7X Patient Table Finger Entrapment Risk

    The Philips AD7 and AD7X patient tables pose a finger entrapment risk during manual repositioning. Operators and service personnel could sustain finger injuries from the gap between the longitudinal guiding rails and tabletop.

    Product
    AlluraXperFD20/15 System Code: (1) 722058
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2025·2025-02-12

    FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals

    Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.

    Product
    PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
    Category
    Medical Device
    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 (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
  • HighFDA (Devices)·Z-1093-2025·2025-02-12

    Philips Azurion patient tables recalled for finger entrapment risk

    Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.

    Product
    Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0495-2025·2025-02-12

    Frozen Chocolate Hex Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling 2,017,614 cases of frozen chocolate hex donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not eat the affected product.

    Product
    item 8201846 GEN CHOC HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0489-2025·2025-02-12

    FGF Yeast Ring Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling over 2 million cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    item 8201839 PBX YST RING DONUT PFD 108x2.12OZ, NET WT 12.88 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2025·2025-02-12

    Philips Azurion and Allura System Patient Tables: Finger Entrapment Risk

    Philips Azurion and Allura system patient tables may trap fingers between the guiding rails and tabletop during manual repositioning, risking finger injury to operators and service personnel.

    Product
    Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0514-2025·2025-02-12

    Sour Cream Cake Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling flavored sour cream cake donuts nationwide due to potential Listeria monocytogenes contamination. Approximately 2.0 million cases distributed in the US and Canada are affected.

    Product
    item 8201886 FLAVOREDSOUR CREAM CAKE DONUT 72x3OZ, NET WT 12.15 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0493-2025·2025-02-12

    Frozen Persian Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling frozen Persian donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201844 GEN GLD PERSIAN DONUT DGH FRZ 132x2.5OZ, NET WT 18.56 LB
    Category
    Food
    Distribution
    Distributed nationwide