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.

10451–10475 of 27206

  • HighFDA (Devices)·Z-2393-2024·2024-07-24

    IV Infusion Pump Set Backcheck Valve Malfunction Recall

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1510-2024·2024-07-24

    Canned Coffee and Oat Milk Beverages Recalled for Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of coffee beverages with expiration dates between June 16, 2024 and April 16, 2025 due to potential under-processing. The affected beverages were distributed nationwide and in Canada.

    Product
    Coffee + Oat Milk + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Enderly Coffee Co. Cotton Headed Ninny Muggins, 12 oz. UPC 8 10149-37028 1. 2. Enderly Coffee Co. Rhino Market, 12 oz. UPC 8 10149-37068 7. 3. Vivid Coffee Maple Oat Milk La
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2024·2024-07-24

    Canned black coffee and maple syrup beverage recalled for potential under-processing

    Snapchill, LLC is recalling Mud LLC Maple Mud canned black coffee with maple syrup beverages (12 oz, UPC 854555007058) nationwide and in Canada due to potential under-processing. Affected products have expiration dates from June 16, 2024 to April 16, 2025.

    Product
    Black Coffee + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Mud LLC Maple Mud, 12 oz. UPC 8 54555-00705 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2024·2024-07-24

    Cyanocobalamin Injection Vials Recalled for Glass Particulate Contamination

    Zydus Pharmaceuticals recalls 432,250 vials of Cyanocobalamin Injection USP due to glass particulate matter. Affected vials are distributed in Tennessee.

    Product
    Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2359-2024·2024-07-24

    Abbott Proclaim 5 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.

    Product
    Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1487-2024·2024-07-24

    Lundberg Family Farms Rice Recalled Due to Possible Rodent-Origin Foreign Object

    Wehah Farms is recalling Lundberg Family Farms Sustainable Wild Blend Gourmet Rice because the product may contain a foreign object of apparent rodent origin. Consumers should not consume the recalled product.

    Product
    Lundberg Family Farms Sustainable Wild Blend Gourmet Rice, 1 lb poly bag
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2365-2024·2024-07-24

    Abbott Proclaim Plus 5 Pulse Generator May Have Shorter Service Life Than Labeled

    Abbott is recalling 38 Proclaim Plus 5 Implantable Pulse Generators because they may reach end of service sooner than product labeling indicates, potentially affecting pain management therapy for affected patients.

    Product
    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2024·2024-07-24

    Infusomat UNIV 60 IV Infusion Pump Set Recalled for Valve Malfunction Risk

    B. Braun is recalling Infusomat UNIV 60 IV infusion pump sets due to a backcheck valve defect that could cause medication backflow between IV containers and prevent priming, potentially resulting in adverse drug reactions or medication loss.

    Product
    Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1512-2024·2024-07-24

    Knowledge Perk Coffee Shandy cans recalled for potential under-processing

    Snapchill, LLC is recalling Knowledge Perk 'The Ace' Coffee Shandy 12 oz cans due to potential under-processing during manufacturing. The recall affects 549,146 cans distributed nationwide in the US and Canada with expiration dates from June 16, 2024 through April 16, 2025.

    Product
    Coffee + Lemonade Concentrate + Vanilla Syrup Canned Beverage packaged under the following brands and sizes: 1. Knowledge Perk "The Ace" Coffee Shandy, 12 oz. UPC 8 10149-37100 4.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2024·2024-07-24

    Medtronic Ascenda Intrathecal Catheter design update to prevent occlusion

    Medtronic is updating the design of its Ascenda Intrathecal Catheter (Models 8780, 8781, 8784) to reduce potential tissue growth into the catheter connector that may cause occlusion. Approximately 111,762 units were distributed worldwide.

    Product
    Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2024·2024-07-24

    Canned Coffee Beverage Recalled for Potential Under-Processing Concerns

    Snapchill, LLC is recalling Fire Grounds Coffee Co Mo Mocha canned beverages nationwide due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee + Chocolate Syrup and Sugar Canned Beverage packaged under the following brands and sizes: 1. Fire Grounds Coffee Co Mo Mocha, 12 oz. UPC 8 50050-85505 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2024·2024-07-24

    Cardura XL Extended Release Tablets Recalled for Failed Impurity Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets 8mg because two lots failed impurity and degradation specifications. Approximately 3,694 bottles were distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2024·2024-07-24

    Snapchill Quivr Canned Tea Recalled for Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Quivr brand canned tea beverages nationwide due to potential under-processing, which may allow pathogenic contamination.

    Product
    Tea Canned Beverage packaged under the following brands and sizes: 1. Quivr Hibiscus Tea, 12 oz. UPC 8 50032-47603 4. 2. Quivr Jasmine Green Tea, 12 oz. UPC 8 50032-47603 4. 3. Quivr Golden Black Tea, 12 oz. UPC 8 60000-38051 5. 4. Quivr Jade Oolong Tea, 12 oz. UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2024·2024-07-24

    Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.

    Product
    Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2410-2024·2024-07-24

    Knee Prosthesis Tibial Component Screws Cannot Be Loosened During Surgery

    The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.

    Product
    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1509-2024·2024-07-24

    Snapchill Coffee and Oat Milk Beverage Recall Due to Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Coffee + Oat Milk Canned Beverage distributed nationwide and in Canada due to potential under-processing that may not have eliminated harmful organisms.

    Product
    Coffee + Oat Milk Canned Beverage packaged under the following brands and sizes: 1. Dreamy Coffee Co. Hint of Chocolate, 12 oz. 2. Shirazi Distribution Cafe Au Lait - Little Wolf Corree Roasters, 12 oz. UPC 8 50044-13040 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2024·2024-07-24

    Oatmeal Daily Moisturizing Body Lotion Recalled Due to Mold Contamination

    Brands International Corporation is recalling Oatmeal Daily Moisturizing Body Lotion (8 fl oz) due to confirmed mold contamination. The recall affects 120,319 bottles distributed nationwide.

    Product
    Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1514-2024·2024-07-24

    Canned tea beverage recalled due to potential under-processing

    Snapchill, LLC is recalling Square One Coffee Roasters Berry Mint Tea with Honey canned beverages due to potential under-processing. The affected cans were distributed nationwide and in Canada.

    Product
    Tea + Honey Canned Beverage packaged under the following brands and sizes: 1. Square One Coffee Roasters Berry Mint Tea with Honey, 12 oz. UPC 8 54555-00743 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2376-2024·2024-07-24

    IV infusion set recalled due to backcheck valve malfunction

    B. Braun is recalling OUTLOOK IV sets due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers and prevent proper priming, potentially resulting in patient injury.

    Product
    OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1499-2024·2024-07-24

    Canned Black Coffee Beverage Recalled for Potential Under-Processing

    Snapchill, LLC is recalling Larry's Coffee Nitro Sweet(ish) canned beverages due to potential under-processing. The recall affects 549,146 cans distributed nationwide and in Canada, with expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee + Sweet Syrup Canned Beverage packaged under the following brands and sizes: 1. Larry's Coffee Nitro Sweet(ish), 12 oz. UPC 8 50050-85511 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2024·2024-07-24

    Abbott Proclaim XR 7 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.

    Product
    Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2394-2024·2024-07-24

    Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction

    B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.

    Product
    Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1496-2024·2024-07-24

    Canned Coffee Beverages Recalled for Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Black Coffee + Sugar beverages under the brands Bold Bean Coffee Roasters and Kahawa 1893 Coffee Inc. due to potential under-processing during manufacturing.

    Product
    Black Coffee + Sugar Canned Beverage packaged under the following brands and sizes: 1. Bold Bean Coffee Roasters The Sweet One, 12 oz. UPC 8 10149-37110 3. 2. Kahawa 1893 Coffee Inc. Sweet Kenyan, 12 oz. UPC 8 50033-95733 4.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2024·2024-07-24

    Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling

    Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.

    Product
    REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1495-2024·2024-07-24

    Black coffee canned beverages recalled nationwide for potential under-processing

    Snapchill, LLC is recalling 549,146 cans of black coffee beverages nationwide and in Canada due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee Canned Beverage packaged under the following brands and sizes: 1. 41 & Change Coffee Co A Finca / Nicaragua Cold Coffee, 12 oz. UPC 1 97644-95863 4. 2. Alchemy Roast Elixir or Life (Gutemala/Huehuetenango Blend) 12 oz. UPC 8 10149-37056 4. 3. Amavida Coffe Roa
    Category
    Food
    Distribution
    Distributed nationwide