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.

7926–7950 of 26961

  • HighFDA (Devices)·Z-0687-2025·2024-12-25

    K-Systems G73 Dry Bath Incubator may exceed target temperature

    CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms when this occurs.

    Product
    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at c
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0286-2025·2024-12-25

    Food-Grade Salt Products Recalled for Foreign Material Contamination

    Compass Minerals America Inc. is recalling approximately 67 metric tons of food-grade salt products due to foreign material contamination. The voluntary recall affects products distributed in Massachusetts, Indiana, Wisconsin, and Canada.

    Product
    Bulk salt product shipped in 1 metric ton tote; 50lb bag Special Purity Granulated Food-Grade Salt with UPC 041582150158; 44lb bag sifto Hy Grade Food Grade Salt, Compass Minerals America Inc. 9900 West 109th Street Overland Park, KS 99219
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0709-2025·2024-12-25

    Medical Imaging Software Recall: mint Lesion Orientation Display Malfunction

    Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in the US and internationally.

    Product
    mint Lesion, Software Versions: 3.9.0 through 3.9.5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0285-2025·2024-12-25

    Impossible Spicy Ground Sausage Recalled for Potential Metal Contamination

    Impossible Foods is recalling Impossible Spicy Ground Sausage due to potential metal pieces in the product. The recall affects 32,536 cases distributed nationwide with use-by dates between June 28, 2025 and January 28, 2026.

    Product
    Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0312-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps Recalled for Metal Contamination

    L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps are being recalled due to potential metal contamination. Products were distributed in CT, KS, MN, OH, and TX.

    Product
    L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271355. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0306-2025·2024-12-25

    Griffith Foods Italian Style Herb Powder Recalled for Metal Contamination

    Griffith Foods has recalled Item 79588401 (Italian Style Herb Powder) in 55 lb bags due to potential metal pieces. Affected lots 577773 and 577774 were distributed to IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 79588401, ITAL STY PD HERB REDUCED EX, 55 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0311-2025·2024-12-25

    L'Oven Fresh KETO Tortilla Wraps recalled for possible metal contamination

    Rise Baking Company is recalling L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps sold at Aldi stores in five states due to potential metal contamination. Affected products carry specific Julian date codes from 24 302 to 24 311.

    Product
    L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0293-2025·2024-12-25

    Yoder's Cashew Crunch hard candy recalled for undeclared milk allergen

    Yoder's Cashew Crunch hard candy is being recalled due to undeclared milk allergen on the label. The product was distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Hard candy packed in clear plastic bag with gold/red label, Yoder's Cashew Crunch, Wt. 7oz, 2620 Hwy. 22, Riverside, IA 52327
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0310-2025·2024-12-25

    Bakestone Brothers Pita Bread Recalled Due to Metal Contamination

    Bakestone Brothers Pita Bread is being recalled due to the presence of metal pieces in the product. Consumers who have purchased this bread should not consume it and should discard it.

    Product
    Bakestone Brothers Pita Bread, 6 Whole Wheat Pitas. Net Wt. 11.4 oz(325g) UPC 0 57391-01002 6. Manufactured by PBF pita Bread Factory Ltd, 8000 Winston Street, Burnaby British Columbia V5A 2H5. Product of Canada
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0146-2025·2024-12-25

    Quala Dental Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.

    Product
    Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0304-2025·2024-12-25

    Spicy Breading Product Recalled for Potential Metal Contamination

    GRIFFITH FOODS LTD has recalled 50-pound bags of Spicy Breading Export (LOT 575830) due to potential metal contamination. Affected product was distributed to IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 42081001, 104023600 SPICY BREADING EXPORT, 50 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0707-2025·2024-12-25

    Duravent Silicone Ventilation Tubes recalled for product substitution error

    Olympus is recalling 984 Duravent Silicone Ventilation Tubes (Model 240075) due to the potential that some units may contain incorrect product—specifically 1.32 mm Tiny T Tubes (Model 70240076) instead of the intended product.

    Product
    Duravent Silicone Ventilation Tube. Model Number: 240075.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-0305-2025·2024-12-25

    Italian Meatball Dry Mix Recalled Due to Metal Contamination

    GRIFFITH FOODS LTD is recalling 25,903 pounds of Italian Meatball Dry Mix due to potential metal pieces in the product. The product was distributed across IL, NY, NC, WI, TX, TN, and GA.

    Product
    Item 18968101, 100138 ITALIAN MBALL DRY MIX EX, 40.84 lb. bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0139-2025·2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2025·2024-12-25

    Ophthalmic solution recalled for lack of sterility assurance

    Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.

    Product
    REGENER-EYES — REGENER-EYES (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2025·2024-12-25

    Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

    Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

    Product
    Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2025·2024-12-25

    OEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect

    GE OEC Medical Systems is recalling 78 OEC 9900 Elite mobile fluoroscopy systems due to insufficient sealing of X-ray tubes. The defect can result in oil leaks and loss of fluoroscopic imaging capability.

    Product
    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application ma
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Drugs)·D-0153-2025·2024-12-25

    OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

    REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    REGENER-EYES — REGENER-EYES (REGENER-EYES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2025·2024-12-25

    K-Systems T47 Warming Plate May Exceed Set Temperatures

    CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0696-2025·2024-12-25

    ET Tube Holder Recalled for Risk of Facial Skin Injury

    Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0297-2025·2024-12-25

    Bulk Candy Coated Popcorn Recalled for Undeclared Milk Allergen

    Yoder's Cashew Crunch Corn, unlabeled bulk candy coated popcorn, is being recalled because milk allergen is not declared. The product was distributed to retail and wholesale locations in Iowa and Georgia.

    Product
    Yoder's Cashew Crunch Corn, bulk candy coated popcorn packaged in clear plastic without label.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0693-2025·2024-12-25

    Bronchoscopic system may lose power due to defective component

    A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.

    Product
    Galaxy System (GAL-001)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0301-2025·2024-12-25

    Artisan Multigrain Baguettes Recalled for Possible Metal Contamination

    Stuyvers Bread is recalling Artisan Multigrain Baguettes (Lot #24313) due to possible metal contamination in a sub-ingredient. The product was distributed to two consignees in California, Connecticut, and Washington.

    Product
    Baguette, Artisan Multigrain. (30 Units/box) 400g/each. Contains: Wheat, Sesame Seeds, Gluten (rye, barley, oat) Lot#24313
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0300-2025·2024-12-25

    Pull-Apart Holiday Rolls Recalled for Possible Metal Contamination

    Stuyvers Bread is recalling Pull-Apart Holiday Rolls due to possible metal contamination in a sub-ingredient. The affected product was distributed to select retailers in California, Connecticut, and Washington.

    Product
    Pull apart Holiday Rolls (cluster bun). (2 Units/bag) 195g/each. Contains: Wheat, Milk Lot#24312
    Category
    Food
    Distribution
    0 states