The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

10751–10775 of 22146

  • HighFDA (Drugs)·D-0597-2024·2024-07-24

    FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.

    Product
    NITROFURANTION — NITROFURANTION (NITROFURANTION)
    Category
    Drug
    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-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-2391-2024·2024-07-24

    Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard

    B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.

    Product
    Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
    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 (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 (Devices)·Z-2396-2024·2024-07-24

    Infusomat SPACE IV infusion sets recalled for backcheck valve malfunction

    Infusomat SPACE IV infusion sets are recalled due to a backcheck valve defect that may cause medication to flow backward into primary IV bags, potentially resulting in medication loss or adverse drug reactions.

    Product
    Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
    Category
    Medical Device
    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 (Devices)·Z-2395-2024·2024-07-24

    Infusomat SPACE Pump IV Set Recalled Due to Backcheck Valve Malfunction

    B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.

    Product
    Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
    Category
    Medical Device
    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 (Food)·F-1497-2024·2024-07-24

    FDA Recalls Black Coffee Beverages Due to Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of Black Coffee + Chocolate Syrup canned beverages marketed under Bold Bean Coffee Roasters and Larry's Coffee brands due to potential under-processing that may allow pathogenic growth.

    Product
    Black Coffee + Chocolate Syrup Canned Beverage packaged under the following brands and sizes: 1. Bold Bean Coffee Roasters The Chocolate One, 12 oz. UPC 8 10149-37108 0. 2. Larry's Coffee Nitro Mocha, 12 oz. UPC 8 50050-85512 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2024·2024-07-24

    Knee Walker Tiller Separation Risk Recalled Due to Fall Hazard

    Medical Depot is recalling Nitro Glide Knee Walker Model 791BL units due to a defect where the tiller may separate from the base assembly. If the device fails, users may fall and sustain injury.

    Product
    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
    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 (Food)·F-1511-2024·2024-07-24

    Canned Coffee Beverage Recalled for Potential Manufacturing Under-Processing

    Snapchill, LLC is recalling Fire Grounds Coffee Co. Vanilla Nito canned beverages due to potential under-processing. Approximately 549,146 cans were distributed nationwide in the United States and Canada.

    Product
    Coffee + Oat Milk + Vanilla Syrup Canned Beverage packaged under the following brands and sizes: 1. Fire Grounds Coffee Co. Vanilla Nito, 12 oz. UPC 8 50050-85504 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2024·2024-07-24

    Snapchill Canned Coffee Beverages Recalled Due to Potential Under-Processing

    Snapchill, LLC recalls Mad Priest Coffee Fallen Angel with Vanilla canned beverages due to potential under-processing. Approximately 549,146 cans with expiration dates between June 16, 2024 and April 16, 2025 are affected.

    Product
    Black Coffee + Vanilla Syrup Canned Beverage packaged under the following brands and sizes: 1. Mad Priest Coffee Fallen Angel with Vanilla, 12 oz. UPC 8 59488-00754 0.
    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-2361-2024·2024-07-24

    Abbott Proclaim 7 Implantable Pulse Generator May Reach End-of-Service Sooner Than Labeled

    Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2024·2024-07-24

    Infusion Pump Set Recalled Due to Valve Malfunction Risk

    B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.

    Product
    Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2024·2024-07-24

    Agilis NxT Steerable Introducer Recalled for Dilators Too Short

    St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.

    Product
    St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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 (Devices)·Z-2373-2024·2024-07-24

    Horizon Bone Densitometer Devices Recalled for Electromagnetic Compatibility Issues

    Hologic Inc. is recalling 2,642 Horizon X-Ray Bone Densitometer units due to non-conformance with electromagnetic compatibility safety standards. The devices exceeded acceptable limits per international technical standard IEC 60601-1-2.

    Product
    Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2024·2024-07-24

    Surgical Hemostatic Device Recalled for Compromised Sterile Barrier

    Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.

    Product
    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2024·2024-07-24

    Abbott Proclaim XR 5 Implantable Pulse Generator Battery Labeling Error

    Abbott Proclaim XR 5 implantable pulse generators may reach end of service sooner than product labeling indicates, affecting approximately 83,511 units worldwide. Patients should contact their healthcare provider for guidance on device monitoring and replacement planning.

    Product
    Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
    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