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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15101–15125 of 27762

  • SevereFDA (Food)·F-0672-2024·2023-12-13

    Bix Produce Mixed Fruit Recall for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Item #12217 mixed fruit (cantaloupe, pineapple, red grapes) due to potential Salmonella contamination. The product was distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Item # 12217 Fruit, Chk Cant/Pine 1/2" w/Grp, 5 lb. containing Cantaloupe, Pineapple, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0611-2024·2023-12-13

    Food Recall: Market Cuts Fruit Mix Products Due to Salmonella

    Market Cuts LLC is recalling fruit mix products distributed in Illinois, Indiana, Michigan, and Wisconsin due to salmonella. The voluntary recall, initiated November 9, 2023, affects 434 units with best-by dates from November 4–9, 2023.

    Product
    Market Cuts Fruit Mix Standard 1/5lb Tray 5 Pound tray; Market Cuts 1 lb Fruit Mix Chunk 1" 1 Pound clamshell UPC 092538000461; Market Cuts Fruit Mix Standard 2/5lb Tray 5 Pound tray; Market Cuts 20 oz Bowl Fruit Small 20 Ounce bowl UPC 092538000577; Freshly Made Mixed Fruit 10 O
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0670-2024·2023-12-13

    Mixed Fruit Products Recalled for Potential Salmonella Contamination

    Bix Produce Mixed Fruit products containing cantaloupe, honeydew, and pineapple are recalled due to potential Salmonella contamination. Consumers should not consume the affected products.

    Product
    Bix Produce Mixed Fruit products containing Cantaloupe, Honeydew, and Pineapple. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following cuts and weights: 1. Item # 12192, Fruit
    Category
    Food
    Distribution
    4 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-0454-2024·2023-12-13

    Red Light Therapy Bed Canopy Strut Detachment Risk Nationwide

    Thor Photomedicine is recalling six THOR NOVO GEN 2.0 XL whole body red light therapy beds due to ball stud component failure. The defect causes gas strut detachment, making the canopy difficult to lift.

    Product
    G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2024·2023-12-13

    Monarch Platform Bronchoscope Software Issue Causes Flipped Display

    Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.

    Product
    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 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-0427-2024·2023-12-13

    ProCuity Hospital Beds: Missing electrical safety tests pose burn and shock risk

    Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
    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-0498-2024·2023-12-13

    Milled Brown Flax Recalled Due to Plastic Contamination Risk

    Scoular Grain Co is recalling 40,000 pounds of Milled Brown Flax (lot REG23268) distributed in Texas and Canada due to plastic foreign object contamination. The product poses a choking and injury hazard if consumed.

    Product
    Milled Brown Flax - MBF9, 50lb bag
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0440-2024·2023-12-13

    Automated Impella Controller Software Issue Prevents Pump Detection

    Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.

    Product
    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0467-2024·2023-12-13

    Staar EVO +VISIAN Implantable Collamer Lens Recalled for Specification Compliance Issue

    Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.

    Product
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0490-2024·2023-12-13

    Blood Ketone Test Strips Recalled for False Negative Results

    Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.

    Product
    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2024·2023-12-13

    DJO EMPOWR Knee System Recall: Incorrect Device in Packaging

    Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.

    Product
    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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-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-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 (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-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-0457-2024·2023-12-13

    Biliary balloon dilators recalled due to design nonconformity and detachment risk

    Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0501-2024·2023-12-13

    RANDOX Total Bilirubin Reagent Recall Due to Elevated Patient Results

    Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.

    Product
    RANDOX Total Bilirubin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2024·2023-12-13

    HeartWare HVAD Ventricular Assist Device Documentation Update

    HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.

    Product
    STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
    Category
    Medical Device
    Distribution
    0 states