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.

9076–9100 of 27089

  • ModerateFDA (Devices)·Z-0030-2025·2024-10-16

    Aligned Medical T and A Pack Recalled for Component Misuse Risk

    Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.

    Product
    Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0024-2025·2024-10-16

    Gelato Ice Cream Recalled for Possible Container Fragmentation

    ALCAS USA CORP. is recalling gelato ice cream packaged in compostable tubs due to possible fragmentation of the container material. Affected products were distributed in the USA, Cayman Islands, and Canada.

    Product
    Gelato ice cream packaged in Compostable Tubs which are labeled in part Vaschetta Accoppiata Compostabile . The gelato is packaged in four (4) sizes of Compostable Tubs: COMPOSTABLE YETI TUB 350 GR/ 500 CC (M) (16.90 fl. oz.) COMPOSTABLE YETI TUB 500 Gr/750 CC (25.36 fl. oz.)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0040-2025·2024-10-16

    Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch

    FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.

    Product
    Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2025·2024-10-16

    Aligned Medical Septo Pack recalled for containing component under FDA recall

    The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

    Product
    Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2025·2024-10-16

    Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch

    Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.

    Product
    Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2025·2024-10-16

    iCast Covered Stent Recalled for Unique Device Identifier Labeling Error

    Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.

    Product
    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1838-2024·2024-10-09

    Kandy brand whole cantaloupes recalled for possible Salmonella contamination

    Eagle Produce LLC is recalling Kandy brand whole cantaloupes due to possible Salmonella contamination. The recalled product (224 cases of 9-count boxes) was distributed to Michigan, Missouri, Ohio, Texas, and Virginia.

    Product
    Whole cantaloupe, brand name Kandy, packed in a corrugated box, 9 count
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0004-2025·2024-10-09

    Gold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil

    FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.

    Product
    Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2025·2024-10-09

    FDA Recalls Veklury Injection Vials for Presence of Glass Particles

    Gilead Sciences recalls 105,000 vials of Veklury (remdesivir) for injection nationwide because glass particles are present in the medication.

    Product
    VEKLURY — VEKLURY (REMDESIVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0003-2025·2024-10-09

    MiniMed Insulin Pumps May Stop Delivering Insulin After Physical Impact

    Medtronic MiniMed insulin pumps (670G, 770G, 780G) that have been dropped or bumped may develop internal battery defects causing premature failure and interrupted insulin delivery, risking dangerously high blood sugar.

    Product
    MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MM
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-0001-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Depletion and Delivery Risk

    Medtronic MiniMed 630G and 700G insulin pumps may experience battery depletion and device shutdown after physical impact, interrupting insulin delivery in diabetic patients.

    Product
    MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Food)·F-0016-2025·2024-10-09

    Raisin Bran Muffins Recalled for Undeclared Milk and Wheat Allergens

    The Posh Bakery, Inc. is recalling Whole Grains Bakery Raisin Bran Muffins (6 oz) due to undeclared whey (milk) and wheat allergens and missing allergen labeling.

    Product
    Whole Grains Bakery labeled "Raisin Bran Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 104 7"
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0003-2025·2024-10-09

    Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil

    Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.

    Product
    Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2025·2024-10-09

    MiniMed Insulin Pumps Recalled for Battery Failure After Physical Impact

    MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.

    Product
    MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809,
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Food)·F-1837-2024·2024-10-09

    Chicken and Duck Eggs Recalled for Potential Salmonella Contamination

    Milo's Poultry Farms is recalling chicken and duck eggs sold in foodservice and consumer packages in Illinois, Michigan, and Wisconsin due to potential Salmonella contamination.

    Product
    Grade A Brown Chicken Eggs, in shell, Bulk 15 dozen. For Foodservice. Keep Refrigerated. Sold with the following brands: 1. Milo's Poultry Farms, N 3873 Valley Road, Bonduel, WI 54107. Organic Eggs from Free Range Hens. 2. M&E Family Farms, Eggs from Free Range Hens. N
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0004-2025·2024-10-09

    Neo-Tee T-Piece Resuscitator circuit flow controller may come apart

    Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.

    Product
    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-3207-2024·2024-10-09

    Percussionaire IPV In-Line Valve Recall: Blue Cap Removal Labeling Update

    Percussionaire is recalling the P5-TEE IPV in-line valve to update labeling and ensure the blue cap is removed before use and delivery of the device.

    Product
    Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3208-2024·2024-10-09

    Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency

    Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.

    Product
    Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0002-2025·2024-10-09

    Kerala Mixture Snack Recalled for Undeclared Wheat Allergen

    Grace Imports recalled Kerala Mixture snack due to undeclared wheat allergen. The supplier failed to disclose wheat on the product label, posing a risk to consumers with wheat allergies.

    Product
    KERALA MIXTURE INGREDIENTS: Gram Flour 48%, Edible Veg Oil (Refined Palmolein Oil) 36%, Peanuts 6%, Roasted Bengal Gram, Salt 1.5%, Chilly powder 1%, Curry leaf, Asafoetida, Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a Factory that Process Peanut
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1836-2024·2024-10-09

    Mini Raspberry Lemon Coffee Cake Recalled for Undeclared Walnuts and Wheat

    Mini Raspberry Lemon Coffee Cake products in Washington were mislabeled and contain undeclared walnuts and wheat. Consumers with allergies to these ingredients should not consume the product and should return it to the store.

    Product
    Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 57297 00745 4. Made with Gluten-Free Ingredients in a Gluten-Friendly Bakery. Macrina Bakery - Kent, WA. Ingredients: CANE SUGAR, GREEK YOGURT (GRADE A PASTEURIZED CULTURED MILK, CREAM, NONFAT MILK), EGGS, RASPBERRIES, B
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3303-2024·2024-10-09

    Urinalysis reagent strips recalled for reduced protein detection sensitivity

    Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.

    Product
    Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0013-2025·2024-10-09

    Big Bottom Milk Chocolate Milk Recalled for Inadequate Pasteurization

    Big Bottom Milk Company is recalling 701 units of Chocolate Milk Grade A (1-pint bottles) distributed in Georgia, North Carolina, and South Carolina due to failure to achieve required pasteurization temperatures.

    Product
    BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Pint (0.473 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 850061506078
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0001-2025·2024-10-09

    KARA BOONDHI Recalled for Undeclared Wheat Allergen

    Grace Imports is recalling KARA BOONDHI due to undeclared wheat allergen on the label. The affected product was distributed to retail stores in Georgia.

    Product
    KARA BOONDHI INGREDIENTS: Gram flour, Edible beg oil (Refined Palmolein Oil), Chilly powder, Curry leaf, pepper, Asafoetida, Corn Flour, Urid dhall, Black salt. Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a FActory that Process Peanuts, Tree nuts,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0004-2025·2024-10-09

    Ceremonial Cacao Paste Recalled for Elevated Lead Levels

    Heart of the Earth ceremonial cacao paste is being recalled due to elevated lead levels in the product. Consumers should not consume this product and should contact a healthcare provider if they have concerns.

    Product
    Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up pouch bags with inner plastic liner with SKU PC-GRUCCP-1LB. Product of Guatemala. Distributed Soul Lift Cacao of Portland, Oregon. The produc
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0006-2025·2024-10-09

    Sqwincher Electrolyte Beverage Mix recalled for potential metal contamination

    Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix (Orange powder, lot 2B0165712) due to potential metal contamination. The product was distributed in 11 states.

    Product
    Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 159016404
    Category
    Food
    Distribution
    11 states