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.

16551–16575 of 88183

  • HighFDA (Food)·F-1589-2023·2023-10-04

    Fenugreek Supplement Bottles Recalled for Pen Fragment Contamination

    Vitality Works is recalling 1,025 bottles of fenugreek capsules due to contamination with pen pieces. No illnesses have been reported.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2633-2023·2023-10-04

    exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning

    Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.

    Product
    exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2023·2023-10-04

    Aquilex Fluid Control System May Cause Fluid Overload During Hysteroscopy

    The Aquilex Fluid Control System (Models AQL-100PBS, AQL-100P) display may freeze at maximum volume (30,000 ml) during long procedures, causing inaccurate fluid monitoring and potential fluid overload.

    Product
    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1572-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Pen Piece Contamination

    Vitality Works, Inc is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules (600mg) due to contamination with pen pieces. The product was distributed to 284 retail stores across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1609-2023·2023-10-04

    Regal Taco Seasoning Recalled for Rodent Feces Contamination

    Regal Foods, Inc. recalled Regal Taco Seasoning in multiple sizes due to rodent feces found in oregano samples. The product was distributed to Georgia, Maryland, Pennsylvania, and Kentucky.

    Product
    REGAL TACO SEASONING 10oz , 25#, 5# various containers.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1570-2023·2023-10-04

    Fenugreek Capsules Recalled for Pen Piece Foreign Material Contamination

    Vitality Works Inc. is recalling 1,025 bottles of 100 vegetarian Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product and return or discard it.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1618-2023·2023-10-04

    Organic walnut product recalled for undeclared cashew allergen

    IO Inspired Organics Organic Raw Walnuts recalled due to undeclared cashews. The product was distributed in six U.S. states; consumers with tree nut allergies should not consume.

    Product
    IO Inspired Organics Organic Raw Walnuts, 5oz bag, UPC 8 63669 74200 7, 9 bags per wholesale case
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2628-2023·2023-10-04

    Ambu aView 2 Advance Monitor Recalled Due to Battery Combustion Risk

    Ambu Inc. is recalling the aView 2 Advance Monitor because multiple impacts can cause the device to short-circuit and potentially combust the lithium-ion battery, resulting in smoke and flames.

    Product
    Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1551-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Pen Piece Contamination

    Vitality Works is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pen pieces. The affected lot was distributed to retail customers across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1550-2023·2023-10-04

    Vitality Works Fenugreek Capsules Recalled for Foreign Material

    Vitality Works is recalling approximately 1,025 bottles of Fenugreek Capsules due to the presence of pen pieces found in the product. The foreign material poses a potential choking hazard.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1594-2023·2023-10-04

    Fenugreek Capsule Supplement Recalled for Pen Piece Contamination

    Vitality Works is recalling 1,025 bottles of 100-count Fenugreek Capsules (600mg) due to contamination with pen pieces. The affected lot is 2023-06871, distributed to stores across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1577-2023·2023-10-04

    Fenugreek Supplement Capsules Recalled Due to Pen Fragments

    Vitality Works, Inc is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pen fragments. The capsules may pose a choking or ingestion hazard if consumed.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0006-2024·2023-10-04

    Cerebelly Smart Bars recalled for visible surface mold

    Cerebelly Inc. has recalled Strawberry Beet flavor Smart Bars (5-pack and 7-pack) due to visible surface mold. Approximately 154,554 selling cartons were distributed across all U.S. states and territories.

    Product
    Cerebelly Smart Bar; Strawberry Beet flavor; 5 pk and 7 pk; ambient storage
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1576-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Foreign Material Contamination

    Vitality Works is recalling 100 vegetarian Fenugreek Capsules (600mg) because bottles may contain pieces of a pen, posing a choking hazard.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1547-2023·2023-10-04

    Fenugreek Supplement Capsules Recalled Due to Pen Pieces

    Vitality Works recalls 1,025 bottles of fenugreek capsules due to foreign material contamination. The capsules may contain pen pieces and should not be consumed.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Bottle with White Polypropylene Cap. Product distributed under multiple brands.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1614-2023·2023-10-04

    Regal Blackening Season recalled for rodent feces contamination

    Regal Foods, Inc. is recalling Regal Blackening Season seasoning due to rodent feces found in oregano samples. The product was distributed to Georgia, Maryland, Pennsylvania, and Kentucky.

    Product
    REGAL BLACKENING SEASON 5#, various containers.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2645-2023·2023-10-04

    Stryker Recalls Expired Cinchlock SS Knotless Anchor Inserter Units

    Stryker Corporation is recalling 96 units of the expired Cinchlock SS Knotless Anchor Inserter (Part Number CAT02462, Lot 19175AE2) distributed nationwide. Expired surgical devices may not perform reliably during use.

    Product
    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1574-2023·2023-10-04

    Fenugreek Capsules Recalled Due to Pen Contamination

    Vitality Works is recalling its 100 vegetarian Fenugreek Capsules due to contamination with pen pieces. The product was distributed to 284 stores across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2634-2023·2023-10-04

    Medical devices recalled due to potential rodent exposure and temperature excursion

    Inmar Supply Chain Solutions recalled various medical devices nationwide due to potential rodent exposure and temperature excursions. Affected products include bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.

    Product
    Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors, adult diapers, COVID-19 test kits, and pregnancy tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2638-2023·2023-10-04

    3M Attest Biological Indicators Recalled for Defective Caps

    3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.

    Product
    3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1587-2023·2023-10-04

    Vitality Works Fenugreek Capsules Recalled Due to Foreign Material Contamination

    Vitality Works is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pieces of a pen (writing utensil). The affected product was distributed to 284 retail stores across the United States.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1556-2023·2023-10-04

    Fenugreek Capsule Supplement Recalled Due to Pen Fragments

    Vitality Works is recalling 1,025 bottles of Fenugreek Capsules due to contamination with pieces of a pen. Consumers should stop using the product and return it to the retailer.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2636-2023·2023-10-04

    ProSun Luxura Vegaz Model 52X UV Tanning Device Safety Circuit Defect Recall

    J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.

    Product
    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1549-2023·2023-10-04

    Fenugreek Capsules Recalled for Pen Pieces Foreign Contamination

    Vitality Works, Inc. is recalling 1,025 bottles of Fenugreek Capsules because pen pieces were found in the product. Consumers should stop use and contact the manufacturer for refund instructions.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1573-2023·2023-10-04

    Fenugreek Supplement Capsules Recalled for Pen Material Contamination

    Vitality Works, Inc is recalling 1,025 bottles of Fenugreek Capsules (90 count, 600mg) because they may contain pieces of a pen. Consumers should stop using the product and contact the manufacturer for a refund.

    Product
    100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
    Category
    Food
    Distribution
    0 states