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.

14051–14075 of 27263

  • HighFDA (Devices)·Z-0377-2024·2023-11-29

    Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly

    Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.

    Product
    Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2024·2023-11-29

    Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk

    FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2024·2023-11-29

    ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk

    The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.

    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: 1SOPT00009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2024·2023-11-29

    Biomet Compress Device Anchor Plug Recall - Metal Burrs May Extend Surgery

    Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through, potentially extending operative time.

    Product
    Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2024·2023-11-29

    Medline Manual Resuscitators Recalled for Backwards Manometer Leak

    Medline manual resuscitators are recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. The defect affects multiple models used in respiratory care distributed nationwide.

    Product
    Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0463-2024·2023-11-29

    Dietary Supplement Recalled for Subpotent Folic Acid Content

    ActiPharma is recalling ACTIRON Dietary Supplement (Lot 13309, Exp. 01/26) distributed in Puerto Rico because FDA testing found the folic acid content did not meet the label claim.

    Product
    ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0462-2024·2023-11-29

    Frozen Gluten-Free Waffles Recalled for Potential Peanut Contamination

    Treehouse Foods is recalling multiple brands of frozen gluten-free blueberry waffles due to potential peanut contamination. Affected products were distributed in California, Iowa, Illinois, Ohio, and Texas.

    Product
    HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant Eagle Blueberry Gluten Free Waffle, 11.3oz, UPC 030034944940 Topco Full Circle Market Gluten Free Waffles - Blueberry, 11.3oz, UPC 036800486980
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0114-2024·2023-11-29

    Lisinopril Tablets Recalled for Stray Amlodipine Tablet Contamination

    NCS Healthcare recalled Lisinopril Tablets USP 20 mg nationwide due to potential presence of stray Amlodipine Besylate 10 mg tablets in certain lots. No illnesses have been reported.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2024·2023-11-29

    Compress Device Short Anchor Plug recalled for potential metal burrs

    Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.

    Product
    Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0370-2024·2023-11-29

    Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.

    Product
    Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2024·2023-11-29

    Prescription esomeprazole magnesium capsules recalled for failed impurity specifications

    Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2024·2023-11-29

    Compress Device Short Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

    Product
    Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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
  • SevereFDA (Food)·F-0435-2024·2023-11-22

    Banana Bread Ice Cream Recalled for Multiple Undeclared Allergens

    Paradise Flavors LLC is recalling its Banana Bread ice cream (4 oz) due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. The product was distributed in Florida only.

    Product
    BANANA BREAD , Ice-cream base, Natural fruit, bread, dehydrated fruit. PARADISE FLAVORS LLC. CONTAINS NUTS. 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-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-0437-2024·2023-11-22

    Paradise Flavors Key Lime Creamsicle frozen treats recalled for undeclared allergens

    Paradise Flavors is recalling Key Lime Creamsicle frozen desserts due to undeclared milk allergen and undeclared food color additives. Consumers with milk allergies should not consume this product.

    Product
    KEY LIME CREAMSICLE, Filtered water, ice-cream base, natural flavoring, artificial color, citric acid and carboxymethylcellulose. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    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-0448-2024·2023-11-22

    Peanut Butter Ice-Cream Base Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling peanut butter ice-cream base distributed in Florida due to undeclared allergens (milk, peanut, soy, and wheat) not listed on the label.

    Product
    PEANUT BUTTER/MAZAPAN, Ice-cream base, Natural Flavor, Artificial Color, sea salt., Distributed by PARADISE FLAVORS LLC, 4 OZ. 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-0449-2024·2023-11-22

    Cookies And Cream Frozen Product Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Paradise Flavors LLC is recalling 318 units of Cookies And Cream frozen product (4 oz) due to undeclared allergens: milk, soy, and wheat. The product was distributed in Florida.

    Product
    Cookies And Cream, distributed by Paradise Flavors LLC, 4 OZ, 120ML, Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states