The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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16401–16425 of 31567

  • HighFDA (Devices)·Z-0494-2024·2023-12-13

    Integra Cranial Access Kit Packaging Defect Compromises Sterility

    Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
    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 (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-0445-2024·2023-12-13

    Elekta Versa HD radiation therapy system detector arm uncontrolled extension risk

    Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.

    Product
    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0426-2024·2023-12-13

    ProCuity Hospital Beds Missing Electrical Safety Test Data

    Stryker's ProCuity bed series model 3009 lacks required electrical safety test documentation, creating a risk of tissue burns or electrical shock. The beds are distributed across North America, Europe, and other regions.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-L-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2024·2023-12-13

    Cranial Access Kit Packaging Defect May Compromise Sterility

    Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.

    Product
    Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility

    Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2024·2023-12-13

    Radiation Therapy System Detector Arm Microswitch Defect May Cause Uncontrolled Extension

    Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.

    Product
    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Devices)·Z-0435-2024·2023-12-13

    ProCurity hospital beds recalled for missing electrical safety testing

    Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0485-2024·2023-12-13

    BAPS Shayona Anjir Roll recalled for undeclared Yellow #5

    BAPS Shayona is recalling its Anjir Roll sweet rolls (12 oz) for containing undeclared Yellow #5 food coloring. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Anjir Roll Sweet rolls made from fig and nut filling Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53005 Contains: Milk, Nuts
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0434-2024·2023-12-13

    ProCurity patient beds recalled for electrical safety testing defects

    Stryker is recalling ProCurity bed series (model 3009) due to missing electrical safety test values that could pose risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.

    Product
    ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2024·2023-12-13

    Integra Cranial Access Kit recalled over outer packaging defect

    Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0483-2024·2023-12-13

    Garden of Life Mushroom Supplement Recalled for Undeclared Soy

    Garden of Life RM-10 mushroom supplement recalled due to undeclared soy, a common allergen. The recall affects 15,119 bottles distributed domestically and internationally; consumers with soy allergies should not use these products.

    Product
    Garden of Life, RM-10, Organically Grown Mushrooms, 60 Vegetarian Caplets, Whole Food Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • 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 (Food)·F-0484-2024·2023-12-13

    Dietary supplement recalled for undeclared soy allergen

    Garden of Life RM-10 ULTRA dietary supplement recalled for undeclared soy. Approximately 8,940 bottles were distributed domestically and internationally.

    Product
    Garden of Life, RM-10 ULTRA, Ultimate Immune System Support60 Vegetarian Caplets, Whole Food Dietary Supplement, 90 Ultra Zorbe Vegetarian Capsules
    Category
    Food
    Distribution
    0 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 (Devices)·Z-0448-2024·2023-12-13

    Monarch Platform bronchoscope recalled for potential software image inversion

    AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.

    Product
    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 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 (Devices)·Z-0439-2024·2023-12-13

    CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction

    CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.

    Product
    CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
    Category
    Medical Device
    Distribution
    15 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-0433-2024·2023-12-13

    ProCuity Hospital Bed Model 3009 Lacks Required Electrical Safety Tests

    Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2024·2023-12-13

    EVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure

    Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 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