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.

10326–10350 of 27089

  • SevereFDA (Devices)·Z-2321-2024·2024-07-24

    Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter

    Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.

    Product
    Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0604-2024·2024-07-24

    Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1479-2024·2024-07-24

    Greens products recalled for potential Listeria monocytogenes contamination

    Solata Food LLC is recalling multiple brands of greens products distributed in NY, NJ, and NH due to potential Listeria monocytogenes contamination. Affected products, totaling 4,382 lbs with expiration dates of June 20–24, 2024, should not be consumed.

    Product
    1. Greens Solata 5050; 6x10 clamshell; UPC: 850021494766 / 2. Greens Gaia Organic 5050; 6x10 clamshell; UPC: 850021494827 / 3. Greens Gaia Organic 50/50 blend; 8x45 clamshell; UPC: 850021494919 / 4. Greens Gaia Organic 50/50; 8x45 clamshell; UPC: 850021494957 / 5. Greens Full Ci
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1478-2024·2024-07-24

    Power Greens Products Recalled Due to Listeria monocytogenes Contamination Risk

    Solata Food LLC is recalling multiple Power Greens products due to potential Listeria monocytogenes contamination. Affected products were distributed in NY, NJ, and NH with expiration dates of 6/20/24 and 6/24/24.

    Product
    1. Greens Full Circle Organic Power Greens; 6x10 Clamshell; UPC: 036800490550 / 2. Greens Gaia Organic Power Greens; 8x45 clamshell; UPC: 850021494889 / 3. Greens Full Circle Organic Power Greens; 8x5 clamshell; UPC: 036800388758 / 4. Greens Solata Power Greens; 8x5 Clamshell; U
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0609-2024·2024-07-24

    StellaLife VEGA Oral Care Spray Recalled for Bacillus Contamination

    StellaLife VEGA Oral Care spray bottles have been recalled due to contamination with multiple Bacillus species organisms. The FDA Class I recall affects 31,811 bottles distributed nationwide to physician offices.

    Product
    STELLALIFE VEGA ORAL CARE — STELLALIFE VEGA ORAL CARE (ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA)
    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-2363-2024·2024-07-24

    Abbott Proclaim 7 Pulse Generator Battery Life Shorter Than Labeled

    Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    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 (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 (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-1507-2024·2024-07-24

    Canned Coffee Beverage Recalled Due to Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of Perkatory Coffee Roasters Three Witches Blend due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Coffee + Non-Dairy Creamer + Sugar + Pumpkin Spice Syrup Canned Beverage packaged under the following brands and sizes: 1. Perkatory Coffee Roasters Three Witches Blend, 12 oz. UPC 8 50044-13023 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration

    B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
    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-2386-2024·2024-07-24

    Infusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow

    B. Braun's Infusomat UNIV. 15 IV infusion pump set is being recalled due to a potential backcheck valve malfunction that could cause medication to backflow from secondary into primary IV containers, potentially resulting in patient injury.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2024·2024-07-24

    Hip Prosthesis Component Mislabeled; Package Size May Not Match Device

    Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.

    Product
    UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
    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 (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 (Drugs)·D-0611-2024·2024-07-24

    Potassium Chloride Extended Release Capsules Recalled for Dissolution Defect

    RemedyRepack Inc. is recalling Potassium Chloride Micro 10mEq K Extended Release Capsules because they fail to meet dissolution specifications, which could affect medication effectiveness.

    Product
    Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2367-2024·2024-07-24

    Abbott Proclaim DRG implantable pulse generator service life shorter than labeled

    Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.

    Product
    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
    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-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 (Devices)·Z-2349-2024·2024-07-24

    Cascade IOMAX Cortical Module recalled for defective circuit board

    Cascade IOMAX Cortical Module devices are recalled due to a defective printed circuit board that may cause unintended electrical stimulation. Affected units were distributed in the U.S. and internationally.

    Product
    Cascade IOMAX Cortical Module, REF: 190296-200
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2411-2024·2024-07-24

    Endo Model SL Tibial Components Recalled for Inoperable Blind Screws

    Waldemar Link is recalling Endo Model SL Tibial Components used in knee replacement surgery because the blind screws on the modular components cannot be loosened during surgery, potentially prolonging procedures and forcing surgeons to change their planned approach.

    Product
    Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2408-2024·2024-07-24

    High Flow Insufflation Tubing Recalled for Incomplete Seals

    Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.

    Product
    Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
    Category
    Medical Device
    Distribution
    Distributed nationwide