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.

13776–13800 of 27206

  • HighFDA (Food)·F-0489-2024·2023-12-13

    BAPS Shayona Kaju Katri Cashew Fudge Recalled for Undeclared Yellow #5 Dye

    BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Kaju Katri Kesar Cashew fudge flavored with saffron Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53065 Contains: Nut
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0437-2024·2023-12-13

    DRX Revolution Mobile X-Ray System Electrical Component Failure Recall

    Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.

    Product
    DRX Revolution Mobile X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0482-2024·2023-12-13

    Dietary Supplement Recalled for Undeclared Soy Allergen

    Garden of Life FYI ULTRA Joint & Cartilage Formula dietary supplement recalled due to undeclared soy. Consumers with soy allergies should not use affected bottles.

    Product
    Garden of Life, FYI ULTRA, ULTIMATE Joint & Cartilage Formula, Whole Food Dietary Supplement, 120 Ultra Zorbe VEGETARIAN CAPSULES
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0493-2024·2023-12-13

    Integra Cranial Access Kit packaging defect compromises device sterility

    Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.

    Product
    Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2024·2023-12-13

    Intraocular Lens Implants Recalled for Specification Non-Compliance

    Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0463-2024·2023-12-13

    Quantum TTC Biliary Balloon Dilator Recall Due to Balloon Detachment Risk

    Wilson-Cook Medical is recalling 157 Quantum TTC Biliary Balloon Dilator devices due to a design defect that may cause balloon detachment during use, potentially requiring emergency retrieval.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0462-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators for Design Nonconformance

    Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0472-2024·2023-12-13

    Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance

    Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0502-2024·2023-12-13

    Cooper Surgical catheter recall due to component detachment risk

    The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.

    Product
    Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0487-2024·2023-12-13

    Bundi Ladoo recalled for undeclared artificial food dyes Yellow 5, Red 40, Green 3

    BAPS Shayona Bundi Ladoo was recalled because it contains undeclared artificial food dyes: Yellow 5, Red 40, and Green 3.

    Product
    BAPS SHAYONA Bundi Ladoo Sweet chickpea flour pearls rolled into spheres Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53094 Contains: Milk, Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0428-2024·2023-12-13

    ProCuity Patient Beds Recalled Missing Electrical Safety Test Values

    Stryker is recalling ProCuity patient beds (model 3009) for missing required electrical safety test documentation, creating a risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2024·2023-12-13

    Atrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process

    Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0495-2024·2023-12-13

    BAPS SHAYONA Surti Ghari sweet dumplings recalled for undeclared soy and Yellow #6

    BAPS SHAYONA Surti Ghari sweet dumplings are recalled due to undeclared soy and Yellow #6 dye. The product was distributed in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Surti Ghari Sweet dumplings stuffed with minced nuts and glazed with clarified butter Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53102 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0471-2024·2023-12-13

    Intraocular lens recall: EVO+VISIAN devices may not meet specifications

    Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0499-2024·2023-12-13

    Milled Golden Flax Recalled for Plastic Foreign Object Contamination

    Scoular Grain Co is recalling Milled Golden Flax MGDF in 50 lb bags due to plastic foreign object contamination. Affected lot numbers REG23261 and REG23268 were distributed to Texas and Canada.

    Product
    Milled Golden Flax MGDF, 50 lb bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0478-2024·2023-12-13

    Medical Device Instruction Update: HVAD Ventricular Assist Device Clarifications

    HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.

    Product
    PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0456-2024·2023-12-13

    NovoTHOR Gen 2.5 XL Red Light Therapy Bed Canopy Gas Strut Detachment Recall

    Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.

    Product
    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2024·2023-12-13

    Medical Catheter Sets Recalled Due to Bonding Material Defect

    CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.

    Product
    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2024·2023-12-13

    Medical Radiation Therapy System Detector Arm Malfunction Poses Uncontrolled Extension Risk

    Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.

    Product
    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0431-2024·2023-12-13

    ProCuity Bed Series Recalled for Electrical Safety Test Failures

    Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2024·2023-12-13

    FDA Recalls Biliary Balloon Dilators Due to Detachment Risk

    Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0497-2024·2023-12-13

    BAPS Shayona fudge recalled for undeclared soy allergen

    BAPS Shayona Sangam Katri Rose and nut fudge is recalled because it contains undeclared soy. The product was distributed to six states: Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Sangam Katri Rose and nut fudge Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53035 Contains: Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Drugs)·D-0141-2024·2023-12-13

    Injectable ceFAZolin Sodium Recalled for Lack of Sterility Assurance

    Wells Pharma is recalling 825 syringes of injectable ceFAZolin sodium distributed in Philadelphia, Pennsylvania, due to lack of assurance that the product meets required sterility standards.

    Product
    ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0482-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan

    Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0491-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Defective Outer Packaging

    Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.

    Product
    Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
    Category
    Medical Device
    Distribution
    Distributed nationwide