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.

10501–10525 of 27206

  • HighFDA (Food)·F-1508-2024·2024-07-24

    FDA Recalls Coffee Beverages for Potential Under-Processing Nationwide

    Snapchill, LLC is recalling Wild Goose Coffee Roasters Draft Latte canned beverages due to potential under-processing. The affected cans may not have been adequately processed to kill pathogens, posing a food safety risk.

    Product
    Coffee + Non-Dairy Creamer + Agave Nectar Canned Beverage packaged under the following brands and sizes: 1. Wild Goose Coffee Roasters Draft Latte, 12 oz. UPC 8 10149-37094 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2024·2024-07-24

    Autotome RX Cannulating Sphincterotome Recalled for Potential Device Malfunction

    Boston Scientific recalls the Autotome RX Cannulating Sphincterotome due to foreign material on the cutting wire that may prevent proper device function and extend procedure time. No injuries reported.

    Product
    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2024·2024-07-24

    Infusomat UNIV. 15 IV Pump Set Recalls Due to Backcheck Valve Malfunction

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets because the backcheck valve may malfunction, potentially causing medication backflow or loss, which could lead to 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: 363430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2024·2024-07-24

    Qiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results

    A heating defect in the Qiagen QIAcube Connect MDx may prevent proper incubation temperatures below 40°C, potentially affecting diagnostic test results.

    Product
    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
    Category
    Medical Device
    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-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 (Food)·F-1502-2024·2024-07-24

    Canned coffee beverages recalled for potential under-processing

    Snapchill LLC is recalling approximately 549,146 cans of ready-to-drink coffee beverages distributed nationwide and in Canada due to potential under-processing.

    Product
    Coffee + Non-Dairy Creamer + Sugar Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Nitro with Sugar and Non-Dairy Creamer, 12 oz. UPC 7 83970-58494 6. 2. Euphoria Coffee Sweetened Latte, 12 oz. UPC 8 10149-37096 0. 3. Kahawa 1893 C
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0608-2024·2024-07-24

    Peritoneal Dialysis Solution Recalled for Tube Weld Failure Risk

    Fresenius is recalling DELFLEX dialysis solution due to tube weld failures causing slow leaks that are difficult to detect. 183 cases affected nationwide.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    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-2377-2024·2024-07-24

    IV Infusion Set Backcheck Valve Malfunction May Cause Medication Loss

    B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.

    Product
    OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2024·2024-07-24

    Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy

    Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.

    Product
    Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2024·2024-07-24

    Abbott Proclaim 5 Pulse Generator May Have Shorter Than Labeled Battery Duration

    Abbott Proclaim 5 Implantable Pulse Generators may have a shorter battery lifespan than labeled, potentially affecting replacement timing for patients.

    Product
    Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
    Category
    Medical Device
    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 (Drugs)·D-0612-2024·2024-07-24

    Pravastatin Sodium Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    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 (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-2383-2024·2024-07-24

    B. Braun Infusomat IV Pump Set Recalled Due to Backflow Risk

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
    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-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-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-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-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-2374-2024·2024-07-24

    BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access

    BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.

    Product
    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC,
    Category
    Medical Device
    Distribution
    Distributed nationwide