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.

8301–8325 of 22104

  • 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 (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 (Food)·F-0527-2025·2025-02-12

    FGF LLC Bavarian Bismark pastry items recalled for potential listeria contamination

    FGF LLC is recalling Bavarian Bismark pastry item 8201936 due to potential listeria monocytogenes contamination. The recall covers all product within expiration produced on or before December 13, 2024, distributed nationwide in the US and Canada.

    Product
    item 8201936 NATURAL & ARTIFICIAL FLAVORED BAVARIAN BISMARK, NET WT 13.16 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
  • HighFDA (Devices)·Z-1081-2025·2025-02-12

    Philips AlluraXper FD20 Biplane Patient Table Finger Entrapment Risk

    Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.

    Product
    AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
    Category
    Medical Device
    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 (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
  • 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-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-1092-2025·2025-02-12

    Philips Azurion patient tables recalled for finger entrapment hazard

    Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.

    Product
    Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
    Category
    Medical Device
    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 (Drugs)·D-0219-2025·2025-02-12

    Hydralazine Hydrochloride Tablets Recalled Due to Impurities and Degradation

    SKY Packaging recalls Hydralazine Hydrochloride 25 mg tablets nationwide due to failed quality specifications for impurities and degradation.

    Product
    HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2025·2025-02-12

    Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters

    Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.

    Product
    UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a he
    Category
    Medical Device
    Distribution
    50 states
  • 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-1107-2025·2025-02-12

    Patient Monitor May Fail to Alarm on Ventilator Disconnect

    Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.

    Product
    IntelliVue Patient Monitor MX400. Model Number: 866060
    Category
    Medical Device
    Distribution
    0 states
  • 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-0488-2025·2025-02-12

    Yeast Ring Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of yeast ring donuts distributed nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    item 8201836 GEN YST RING DONUT ZGT PFD 78x3OZ, NET WT 13.16 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-0513-2025·2025-02-12

    FGF Persian Yeast Donuts Recalled Nationwide for Potential Listeria Contamination

    FGF, LLC is recalling Persian yeast donuts due to potential Listeria monocytogenes contamination. The recall affects all product produced on or before December 13, 2024.

    Product
    item 8201884 PERSIAN YST DONUT PFD 46x3.5 OZ, NET WT 9.06 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-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 (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 (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 (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