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.

7401–7425 of 27089

  • 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-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 (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 (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-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-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-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 (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 (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-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 (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-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 (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-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 (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-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-0503-2025·2025-02-12

    FGF Pumpkin Cake Rings Recalled Due to Listeria Contamination Risk

    FGF's Just Baked Pumpkin Cake Rings are being recalled due to potential listeria monocytogenes contamination. Consumers should discard the product or return it to the point of purchase.

    Product
    item 8201866 JUST BAKED PUMPKIN CAKE RINGS 144x2.45 OZ, NET WT 22.05 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-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-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
    0 states
  • 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-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-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 (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-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