The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

7226–7250 of 26961

  • 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-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-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 (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-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 (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-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-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-0478-2025·2025-02-12

    Fluff Bars Recalled Due to Potential Listeria Monocytogenes Contamination

    FGF, LLC is recalling item 8201810 Fluff Bars distributed nationwide to the US and Canada due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    item 8201810 FLUFF BAR 78x2.75 OZ, NET WT 12.07 LB
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2025·2025-02-12

    NeiMed NasoGel nasal spray recalled due to stability failure

    Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.

    Product
    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
    Category
    Medical Device
    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-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-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 (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 (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-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 (Devices)·Z-1097-2025·2025-02-12

    PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach

    Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.

    Product
    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk 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-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-0470-2025·2025-02-12

    Cake Donut Rings Recalled for Potential Listeria Contamination

    FGF, LLC is recalling cake donut rings due to potential contamination with Listeria monocytogenes. Distribution included nationwide US and Canada.

    Product
    item 8201779 GEN PLN CAKE DONUT RINGS PFD 90x2.5 OZ, NET WT 12.66LB
    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-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 (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 (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