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 (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-0031-2025·2024-10-16

    Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component

    Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.

    Product
    Aligned Medical Tonsil Pack REF AMS14809 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-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
  • 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-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 (Devices)·Z-0044-2025·2024-10-16

    MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error

    Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.

    Product
    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
    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 (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 (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
  • 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-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 (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-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 (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 (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 (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-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
  • HighFDA (Devices)·Z-0019-2025·2024-10-09

    Hemodialysis console blood leak sensor may fail to trigger alarm

    A component in certain Tablo Hemodialysis consoles may fail to detect small blood leaks promptly, potentially causing symptoms like hypotension, fatigue, and dizziness if undetected blood loss occurs.

    Product
    Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
    Category
    Medical Device
    Distribution
    46 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 (Devices)·Z-3308-2024·2024-10-09

    DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization

    DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.

    Product
    DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0003-2025·2024-10-09

    Spicy Murukku Snack Recalled for Undeclared Wheat Allergen

    Grace Imports is recalling Spicy Murukku snack due to undeclared wheat on the label. Consumers with wheat allergies face serious health risks from unlabeled exposure.

    Product
    SPICY MURUKKU INGREDIENTS: Rice Flour, Edible Veg Oil (Refined Palmolein Oil), Salt, Salt, Chilly powder, Roasted Bengal Gram Flour***Asafoetida, Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a Factory that Process Peanuts, Tree nuts, Soy, Milk, Wh
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0007-2025·2024-10-09

    Pluvicto Radiopharmaceutical Drug Recalled Due to Manufacturing Quality Deviations

    Advanced Accelerator Applications is recalling 99 doses of Pluvicto (lutetium LU-177 injection) due to manufacturing quality deviations. The affected lots were distributed to six states.

    Product
    Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
    Category
    Drug
    Distribution
    6 states
  • HighFDA (Devices)·Z-3312-2024·2024-10-09

    Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring

    Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.

    Product
    DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3305-2024·2024-10-09

    Atellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.

    Product
    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide