The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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15376–15400 of 27762

  • HighFDA (Devices)·Z-0326-2024·2023-11-29

    Alinity c Iron Reagent Recalled for Falsely Elevated Test Results

    The FDA is recalling Alinity c Iron Reagent lots due to inaccurate results. The reagent produces falsely elevated patient iron values and may prevent proper quality control verification.

    Product
    Alinity c Iron Reagent, Reference Number 08P3920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2024·2023-11-29

    Compress Device Short Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (22 MM) used in orthopedic surgery because they may contain metal burrs in the transverse holes that could prevent drill or pin passage and extend surgical procedures.

    Product
    Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2024·2023-11-29

    BD Gravity Infusion Sets Labeled DEHP-Free But Contain DEHP

    BD gravity blood infusion sets labeled as free of DEHP (di(2-ethylhexyl) phthalate) actually contain the substance. The recall affects products distributed worldwide through July 31, 2026.

    Product
    BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2024·2023-11-29

    Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk

    Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.

    Product
    Achieva 1.5T Conversion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2024·2023-11-29

    Medtronic Mo.Ma Ultra Cerebral Protection Device manifold stickers mislabeled

    Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2024·2023-11-29

    Ventlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk

    SunMed Holdings is recalling Ventlab AirFlow manual resuscitators nationwide due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Users should immediately discontinue use and contact the manufacturer.

    Product
    Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2024·2023-11-29

    IRON assay kits recalled for inaccurate diagnostic results

    Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.

    Product
    IRON assay, Reference Numbers 6K95-41 and 6K95-30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2024·2023-11-29

    Robotic patient positioning system may move unexpectedly after interruption

    The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2024·2023-11-29

    Rhinolaryngoscope Models Recalled for Unvalidated Air Drying Process

    Aizu Olympus rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) are recalled. The air-drying process for the instrument channel was not validated, and water remaining in some devices after repair poses contamination and infection risk.

    Product
    Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2024·2023-11-29

    Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results

    Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.

    Product
    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0429-2024·2023-11-22

    Paradise Flavors frozen cappuccino ice-cream recalled for undeclared milk

    Paradise Flavors LLC is recalling 60 units of its frozen cappuccino ice-cream (4 oz pouches) from Florida due to undeclared milk allergen, which poses a serious risk to consumers with milk allergies.

    Product
    CAPPUCCINO, Ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0440-2024·2023-11-22

    Paradise Flavors frozen mamey recalled for undeclared milk allergen

    Paradise Flavors LLC is recalling 80 units of frozen MAMEY product due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    MAMEY, PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0443-2024·2023-11-22

    Frozen Ice Cream Base Recalled for Undeclared Milk Allergen and Food Colorings

    Paradise Flavors LLC recalls Dulce de Leche ice-cream base (4 oz) for undeclared milk allergen and color additives. The recall affects 210 units distributed in Florida.

    Product
    DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0426-2024·2023-11-22

    Vanilla Ice Cream Base Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC is recalling vanilla ice cream base due to undeclared milk allergen and color additives. Consumers with milk allergies should not use this product.

    Product
    VANILLA, Ice-cream base, Natural flavor, artificial flavor and coloring. Distributed By Paradiose Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0444-2024·2023-11-22

    Chocolate ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC is recalling Chocolate with Almonds ice-cream products due to undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with these allergies should discard the product.

    Product
    CHOCOLATE WITH ALMONDS, ice-cream base, chocolate powder, natural flavoring, PARADISE FLAVORS, 4oz, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0457-2024·2023-11-22

    Frozen ice cream base recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling Chunky Mango frozen ice cream base for containing undeclared milk allergen and color additives. The product poses a health risk to consumers with milk allergies.

    Product
    CHUNKY MANGO, ice-cream base, natural flavoring, artificial flavor and color. 4 OZ, 120ml. DISTRIBUTED BY: Paradise Flavors LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0427-2024·2023-11-22

    Butter pecan ice cream recalled for undeclared allergens and color additives

    Paradise Flavors LLC is recalling BUTTER PECAN ice cream due to undeclared milk and tree nut allergens and undeclared color additives. The product was distributed domestically in Florida.

    Product
    BUTTER PECAN, Ice-cream base, Natural flavor, graham crackers, artificial color, citric acid, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0438-2024·2023-11-22

    Frozen Chocolate Razzberry Cake Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC is recalling Chocolate Razzberry Cake (Gancito) frozen dessert due to undeclared milk, peanuts, soy, and wheat allergens, plus undeclared color additives.

    Product
    CHOCOLATE RAZZBERRY CAKE (GANCITO). INGREDIENTS: Icecream base, Natural flavor, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0408-2024·2023-11-22

    Ice cream recall: Undeclared egg allergen in Guilt Free vanilla

    TH Searcy LLC is recalling Guilt Free No Sugar Added Ice Cream due to undeclared egg allergen. The recall affects 34,500 retail units distributed through Walmart, Kroger, and Associated Wholesale Grocers across nine states.

    Product
    Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1.5qts
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0439-2024·2023-11-22

    Paradise Flavors Rice Pudding Ice Cream Mix Recalled for Undeclared Milk

    Paradise Flavors Arroz con Leche rice pudding ice cream mix is recalled due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    ARROZ CON LECHE/RICE PUDDING, Ice cream MIX, Filtered water, Natural Rice, cinamon and caramel, DISTRIBUTOR PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0453-2024·2023-11-22

    Paradise Flavors Frozen Chocolate Ice Cream Recalled for Undeclared Milk and Soy

    Paradise Flavors LLC is recalling frozen chocolate ice cream (4 OZ/120 ML packages) distributed in Florida due to undeclared milk and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    CHOCOLATE, ice-cream base, chocolate powder, natural flavoring,. PARADISE FLAVORS, 4 OZ, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0445-2024·2023-11-22

    Frozen ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC recalled Ferrero Rocher ice-cream base distributed in Florida due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. Consumers should not consume this product if allergic to these substances.

    Product
    Ferrero Rocher, Ice-cream base, Hazelnut, Nutella, Penuts, Cacao, Rich Chocolate, Artificial flavoring., DISTRIBUTED BY: PARADISE FLAVORS LLC. 4oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0458-2024·2023-11-22

    Paradise Flavors Soursop Ice-Cream Base Recalled for Undeclared Milk

    Paradise Flavors is recalling its 4 oz Guavanana (soursop) ice-cream base because it contains undeclared milk, a major allergen that poses health risks to consumers with milk allergies.

    Product
    GUANAVANA (SOURSOP/GUANABANA), ice-cream base, natural flavoring. PARADISE FLAVORS. 4 OZ, 120ml. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0425-2024·2023-11-22

    Guava Jelly Ice Cream Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors is recalling 86 units of frozen guava jelly ice-cream product due to undeclared milk allergen and color additives (FD&C yellow #5, yellow #8, red #40). The product was distributed only in Florida.

    Product
    GUAVA JELLY, Ice-cream base, natural flavoring, artificial coloring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0442-2024·2023-11-22

    Ice cream base from Florida recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling FLORIDA SUNRISE/CHEMIS ice cream base due to undeclared milk allergen and undeclared color additives. The product was distributed within Florida.

    Product
    FLORIDA SUNRISE/CHEMIS, Paradise Flavors LLC, Ice-cream base, natural flavoring, artificial flavor and color., DISTRIBUTED BY PARADISE FLAVORS LLC, 3 oz, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states