The Recall Desk

Archive

February 2025 recalls

506 recalls were announced in February 2025.

What the numbers show

Critical
7
Severe
122
High
357
Moderate
20

Of the 506 recalls this month scored against our rubric, 1% are Critical, 24% are Severe.

301–400 of 506

  • HighFDA (Food)·F-0525-2025·2025-02-12

    Donuts Recalled for Potential Listeria Monocytogenes Contamination

    FGF LLC is recalling egg-shaped donuts nationwide due to potential Listeria monocytogenes contamination. Approximately 2,017,614 cases were distributed in the US and Canada.

    Product
    item 8201926 FBALL/EGG SHPD DONUT PFD 78 X 2OZ, NET WT 8.78 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 (Drugs)·D-0218-2025·2025-02-12

    Prescription injection recalled for failed stability test results

    Teva Pharmaceuticals is recalling Granix injection due to failed stability test results showing one peptide did not meet specification limits.

    Product
    GRANIX — GRANIX (TBO-FILGRASTIM)
    Category
    Drug
    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-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-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-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-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
    2 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-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-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-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-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 (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-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-1046-2025·2025-02-12

    X-Ray Imaging System May Continue Exposure Beyond Safety Limit

    GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.

    Product
    Optima XR646 HD. X-Ray imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0520-2025·2025-02-12

    Yeast Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling yeast donuts nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    item 8201919 BAR YST DONUT UNFLD PFD 74x3OZ, NET WT 12.49 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 (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-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
    2 states
  • HighFDA (Food)·F-0483-2025·2025-02-12

    Raspberry Paczki Recalled Nationwide for Potential Listeria Monocytogenes Contamination

    FGF, LLC is recalling 2,017,614 cases of Naturally and Artificially Flavored Raspberry Paczki nationwide due to potential contamination with Listeria monocytogenes. Consumers should not consume the product.

    Product
    item 8201815 NATURALLY AND ARTIFICIALLY FLAVORED RASPBERRY PACZKI 66x4 OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0528-2025·2025-02-12

    Unfilled Bismarck Donuts Recalled Due to Listeria Contamination Risk

    FGF, LLC is recalling over 2 million cases of unfilled Bismarck donuts due to potential Listeria monocytogenes contamination. The recall affects products distributed nationwide in the US and Canada.

    Product
    item 8202731 UNFLD BISMARK DONUT PFD 78X3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0460-2025·2025-02-12

    Monkey Spit BBQ Sauce recalled for undeclared milk allergen

    Monkey Spit Monkey Mop BBQ Sauce is recalled because it contains undeclared milk from butter, a common allergen. Consumers with milk allergies should not consume this product.

    Product
    Monkey Spit "Monkey 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 Monkey Spit, LLC, UPC#8 54540 00206 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2025·2025-02-12

    Sysmex PS-10 Sample Preparation System Recalled for False Test Results

    Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.

    Product
    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
    Category
    Medical Device
    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-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 (Food)·F-0500-2025·2025-02-12

    Just Baked Eclairs Recalled Nationwide Due to Listeria Contamination Risk

    FGF, LLC is recalling Just Baked Eclairs nationwide in the US and Canada due to potential Listeria monocytogenes contamination. All products produced on 12/13/24 or earlier are affected.

    Product
    item 8201863 JUST BAKED ECLAIRS 84x2.36 OZ, NET WT 12.39 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-0521-2025·2025-02-12

    FDA Recalls Apple Crisp Cake Donuts for Potential Listeria Contamination

    FGF, LLC recalls Apple Crisp Cake Donuts for potential Listeria monocytogenes contamination. Approximately 2,017,614 cases are affected.

    Product
    item 8201920 APPLE CRISP CK DONUT PFD 78x3OZ, NET WT 13.16 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (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 (Devices)·Z-1102-2025·2025-02-12

    ECG cable shipped with incomplete cleaning and disinfection instructions

    Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.

    Product
    LIFEPAK 35 ECG cable REF 11111-000041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0505-2025·2025-02-12

    FGF Twist Donuts Recalled Due to Listeria Contamination Risk

    FGF's Twist Donuts are being recalled nationwide in the US and Canada due to potential Listeria monocytogenes contamination. The recall affects approximately 2 million cases produced on or before December 13, 2024.

    Product
    item 8201868 GEN TWIST DONUT ZGT PFD 84x1.75 OZ, NET WT 12.93 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0512-2025·2025-02-12

    FGF LLC Recalls Unfilled Bismarck Donuts for Listeria Contamination Risk

    FGF LLC is recalling 2,017,614 cases of unfilled Bismarck donuts nationwide due to potential listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    item 8201883 UNFLD BISMARK DONUT PFD 57x2.75OZ, NET WT 8.82 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0504-2025·2025-02-12

    Just Baked Pumpkin Cake Munchkins recalled for potential Listeria contamination

    FGF, LLC is recalling Just Baked Pumpkin Cake Munchkins nationwide due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    item 8201867 JUST BAKED PUMPKIN CAKE MUNCHKINS 440x0.47 OZ, NET WT 12.93 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0498-2025·2025-02-12

    FGF LLC Just Baked Cake Rings Recalled for Potential Listeria Contamination

    FGF, LLC recalls approximately 2,017,614 cases of Just Baked Cake Rings distributed nationwide due to potential contamination with Listeria monocytogenes.

    Product
    item 8201859 JUST BAKED CAKE RING 144x2.45 OZ, NET WT 22.05 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2025·2025-02-12

    Newborn Resuscitator Kit Recalled for Inline Spring Defect

    414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.

    Product
    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Devices)·Z-1078-2025·2025-02-12

    Philips AlluraXper Patient Tables Pose Finger Entrapment Risk

    Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to operators and service personnel.

    Product
    AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
    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-1079-2025·2025-02-12

    Philips Allura patient tables recall due to finger entrapment risk

    Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.

    Product
    Allura Xper FD10C System Code: (1) 722001
    Category
    Medical Device
    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-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-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 (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-1076-2025·2025-02-12

    Philips Allura CV20 patient tables risk finger entrapment during repositioning

    The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.

    Product
    Allura CV20 System Code: 722031
    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-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 (Food)·F-0519-2025·2025-02-12

    FGF Cake Sticks Recalled for Potential Listeria Contamination

    FGF cake sticks are being recalled nationwide and in Canada due to potential Listeria monocytogenes contamination. Consumers should not eat the product and should return it to retailers.

    Product
    item 8201906 JUST BAKED CAKE STICKS 116x2.9 OZ, NET WT 21.03 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0526-2025·2025-02-12

    Apple Fritter Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Apple Fritter Donuts (item 8201927) due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201927 APPLE FRITTER DONUT PFD 70 X 3.5OZ, NET WT 13.78 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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-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-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 (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-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
  • 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 (Food)·F-0510-2025·2025-02-12

    FGF Donuts Recalled Nationwide Due to Listeria Contamination Risk

    FGF ring donuts recalled nationwide for potential Listeria monocytogenes contamination. The recall covers 2,017,614 cases produced through December 13, 2024.

    Product
    item 8201879 RING RND DONUT ZGT PDF 96x2.25 OZ, NET WT 12.15 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 (Food)·F-0479-2025·2025-02-12

    Sour Cream Cake Donuts Recalled for Potential Listeria Contamination

    FGF, LLC is recalling Old Fashioned Sour Cream Cake Donuts due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201811 OLD FASHIONED NATURALLY AND ARTIFICIALLY FLAVORED SOUR CREAM CAKE DONUTS 90x2.5 OZ, NET WT 12.66 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-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-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 (Devices)·Z-1109-2025·2025-02-12

    IntelliVue Patient Monitor MX500 may fail to generate critical alarms

    Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.

    Product
    IntelliVue Patient Monitor MX500. Model Number: 866064
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0529-2025·2025-02-12

    FGF Vanilla Mini Cake Donut Rings Recalled for Listeria Contamination Risk

    FGF, LLC is recalling 2,017,614 cases of vanilla mini cake donut rings 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 8202891 PLAIN VANILLA MINI CAKE DONUT RING BULK 240X1.25OZ, NET WT 16.88 LB
    Category
    Food
    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-0482-2025·2025-02-12

    Bavarian Paczki Recalled for Listeria Monocytogenes Contamination Risk

    FGF, LLC is recalling Bavarian Paczki (item 8201814) due to potential Listeria monocytogenes contamination. The recall affects 2,017,614 cases distributed nationwide in the US and Canada.

    Product
    item 8201814 BAVARIAN PACZKI 66x4OZ, NET WT 14.85 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0465-2025·2025-02-12

    FDA Recalls Greenwise Organic Pecan Halves for Undeclared Walnuts

    The FDA has recalled Greenwise Organic Pecan Halves (8-ounce bags) due to undeclared walnuts, a major allergen. The affected product was distributed in eight southeastern states.

    Product
    Greenwise Organic Pecan Halves 8 ounce, plastic printed package marked with lot # 18228 and with a best by date of April.23.2025 stamped on front UPC: 041415212336
    Category
    Food
    Distribution
    8 states
  • 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 (Drugs)·D-0215-2025·2025-02-12

    Prescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications

    Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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 (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 (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-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 (Devices)·Z-1085-2025·2025-02-12

    Finger entrapment hazard in Philips Allura fluoroscopy patient tables

    Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing injury.

    Product
    Allura Xper FD20/20 System Code: (1) 722038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2025·2025-02-12

    IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection

    Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.

    Product
    IntelliVue Patient Monitor MX550. Model Number: 866066
    Category
    Medical Device
    Distribution
    2 states
  • 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
  • ModerateFDA (Devices)·Z-1103-2025·2025-02-12

    Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening

    Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.

    Product
    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1112-2025·2025-02-12

    Beckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures

    Beckman Coulter Inc. is recalling specific lots of Access PCT Reagent Pack due to high rates of calibration failures that delay test result reporting on immunoassay systems used in healthcare and laboratory settings.

    Product
    Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2025·2025-02-12

    Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening

    The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and Canada.

    Product
    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2025·2025-02-12

    Timolol Maleate eye drops recalled for defective dropper cap

    FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0222-2025·2025-02-12

    Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength

    PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.

    Product
    GUAIFENESIN AND CODEINE PHOSPHATE — GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·25V075000·2025-02-10

    Winnebago LP tank mounting fasteners may be improperly tightened

    Winnebago is recalling certain 2025 recreational vehicles because the LP tank mounting bracket fasteners may have been improperly tightened, causing the tank to detach.

    Product
    WINNEBAGO — WINNEBAGO NAVION, MINNIE WINNIE, VITA, VIEW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V070000·2025-02-07

    Storyteller Overland Recalls MODE XO Vehicles Due to Seat Mounting Defect

    Storyteller Overland is recalling 2024-2025 MODE XO vehicles because improperly welded seat floor mounting systems may loosen or detach, increasing injury risk.

    Product
    STORYTELLER OVERLAND — STORYTELLER OVERLAND MODE XO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V050000·2025-02-07

    Mercedes-Benz 2024 EQB 250 Electric Vehicle Battery Fire Risk

    Mercedes-Benz is recalling certain 2022–2025 EQB 250, EQB 300 4MATIC, and EQB 350 4MATIC models due to a high-voltage battery that may fail internally and cause vehicle fire while parked or driving.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQB 250+, EQB 250, EQB 350 4MATIC, EQB 300 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V071000·2025-02-07

    2025 Volvo EX90 Headlight Shutter Software Defect Recall

    Volvo is recalling 2025 EX90 vehicles because a software error in the low power controller may cause headlight shutters to close while driving, reducing visibility and increasing crash risk.

    Product
    VOLVO — VOLVO EX90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V068000·2025-02-07

    Zeekr Recalls One 2025 RT Vehicle for Air Bag Protection Defect

    Zeekr is recalling one 2025 RT vehicle because the seat position may prevent side curtain and passenger air bags from providing adequate neck protection during a crash.

    Product
    ZEEKR — ZEEKR RT (OJAI)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V074000·2025-02-07

    2022–2025 Husqvarna and GASGAS motorcycles recalled for brake caliper cracking

    KTM North America is recalling 2022–2025 Husqvarna FE 350S and FE 501S motorcycles, along with 2024–2025 GASGAS ES 350 and ES 500 models, due to front brake calipers that may crack and cause loss of front brake function.

    Product
    HUSQVARNA — HUSQVARNA, GASGAS FE 350S, ES 500, ES 350, FE 501S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V069000·2025-02-07

    2024–2025 Forest River Rockport work trucks E-Track system fastener failure recall

    Forest River is recalling certain 2024–2025 Rockport work trucks because incorrect fasteners may have been used to install the optional E-Track Cargo Tie Down system. The fasteners can fail, causing the system to detach from the wall and increase the risk of injury.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V067000·2025-02-07

    Zeekr Recalls One 2025 RT Vehicle for Air Bag Software Defect

    Zeekr is recalling one 2025 RT vehicle because the occupant weight sensor software may misclassify passengers or disable the air bag, increasing crash injury risk.

    Product
    ZEEKR — ZEEKR RT (OJAI)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V066000·2025-02-07

    Zeekr Recalls One 2025 RT Vehicle for Air Bag Deployment Issue

    Zeekr is recalling one 2025 RT vehicle because the C-Pillar trim may prevent the side curtain air bag from fully deploying, increasing injury risk.

    Product
    ZEEKR — ZEEKR RT (OJAI)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V061000·2025-02-07

    Grand Design Solitude Fifth Wheel Trailers Step Tread Defect Recall

    Grand Design is recalling certain 2019–2024 Solitude fifth wheel trailers because the step tread joints may be unsupported, causing the tread to break and increasing the risk of injury.

    Product
    GRAND DESIGN — GRAND DESIGN SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V073000·2025-02-07

    Nikola TRE FCEV Hydrogen Tank Mounting Bolts May Cause Fuel Leak

    Nikola is recalling certain 2024–2025 TRE FCEV trucks because hydrogen tank mounting block bolts may be too long and damage the tank, creating a fire risk.

    Product
    NIKOLA — NIKOLA TRE FCEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V072000·2025-02-07

    Entegra and Jayco Recreational Vehicles Fuel Tank Support Bracket Fire Risk

    Jayco, Inc. is recalling certain 2021–2025 Entegra Launch and Jayco Terrain recreational vehicles. Grey water tank support brackets may contact and damage the fuel tank, causing a leak and fire risk.

    Product
    JAYCO — JAYCO, ENTEGRA TERRAIN, LAUNCH, LAUNCH LE, TERRAIN LE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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