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.

8276–8300 of 22104

  • HighFDA (Devices)·Z-1101-2025·2025-02-12

    Dental implants recalled for manufacturing defect affecting sterile packaging

    Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.

    Product
    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0469-2025·2025-02-12

    Dierbergs Kitchen Mac & Cheese recalled for undeclared wheat allergen

    Dierbergs Markets recalls 298 packages of Mac & Cheese due to labeling errors that fail to disclose wheat allergens. The product was distributed to Missouri and Illinois retailers with a use-by date of 1/9/2025.

    Product
    Dierbergs Kitchen 16 oz Mac & Cheese packaged in a black plastic container with a clear plastic lid with a white label, The label states "Dierbergs Kitchen Homestyle Mashed Potatoes UPC 231220-006538"
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0490-2025·2025-02-12

    Frozen Persian Donuts Recalled Due to Listeria Contamination Risk

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

    Product
    item 8201841 GEN PERSIAN DONUT DGH FRZ 168x2OZ, NET WT 18.90 LB
    Category
    Food
    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 (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
    0 states
  • HighFDA (Food)·F-0491-2025·2025-02-12

    Frozen Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of frozen donuts nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    item 8201842 GEN BAR DONUT DGH FRZ 132x2OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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-0492-2025·2025-02-12

    FGF Frozen Bismark Donuts Recalled Due to Listeria Contamination Risk

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

    Product
    item 8201843 GEN BISMARK DONUT DGH FRZ 144x2OZ, NET WT 16.20 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 (Devices)·Z-1114-2025·2025-02-12

    Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues

    US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.

    Product
    Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0481-2025·2025-02-12

    FGF Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling dual-filled chocolate and Bavarian yeast ring donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed in the US and Canada.

    Product
    item 8201813 DUAL FILLED NATURALLY & ARTIFICIALLY FLAVORED CHOCOLATE AND BAVARIAN FILLED YEAST RING DONUT 80x3.1OZ, NET WT 13.97 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0518-2025·2025-02-12

    Just Baked Blueberry Cake Ring Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Just Baked Blueberry Cake Ring products for potential Listeria monocytogenes contamination. Approximately 2.0 million cases distributed nationwide to the US and Canada with production dates on or before December 13, 2024.

    Product
    item 8201905 JUST BAKED BLUEBERRY CAKE RING NATURALLY AND ARTIFICIALLY FLAVORED 135x2.5OZ, NET WT 21.09 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2025·2025-02-12

    Surgical sutures recalled for potential sterility breach

    Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.

    Product
    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2025·2025-02-12

    GE Discovery XR656 HD X-ray system AEC control malfunctions during imaging

    GE Medical Systems is recalling the Discovery XR656 HD X-ray imaging system due to a malfunction in the Automatic Exposure Control (AEC) feature. The defect allows continued X-ray exposure beyond intended limits without requiring operator acknowledgment.

    Product
    Discovery XR656 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2025·2025-02-12

    Philips Azurion Patient Tables Recalled for Finger Entrapment Risk

    Philips Azurion patient tables used in medical imaging systems can trap fingers between the tabletop and rails during manual repositioning, potentially causing finger injury to operators and service personnel.

    Product
    Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
    Category
    Medical Device
    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 (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-0496-2025·2025-02-12

    Frozen donuts recalled for potential listeria monocytogenes contamination

    FGF, LLC is recalling frozen donuts nationwide due to potential contamination with listeria monocytogenes. Consumers should not consume the product and should discard or return it.

    Product
    item 8201848 GEN HEX RG DONUT DGH FRZ 96x2.75OZ, NET WT 14.86 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
  • HighFDA (Food)·F-0487-2025·2025-02-12

    JUST BAKED Yeast Munchkins Recalled for Potential Listeria Contamination

    FGF, LLC is recalling JUST BAKED Yeast Munchkins nationwide due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    item 8201835 JUST BAKED YEAST MUNCHKINS 350x0.39 OZ, NET WT 8.49 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V899000·2025-02-12

    2024 Mack Commercial Trucks Steering Gear Assembly Defect Recall

    Mack is recalling approximately 284 certain 2024 Pinnacle, Anthem, and Terrapro commercial trucks with incorrectly assembled steering gear assemblies that could cause loss of steering control and increase crash risk. Dealers will inspect and replace defective gears free of charge.

    Product
    MACK — 2024 MACK PINNACLE (PI)
    Category
    Vehicle
    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