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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4851–4875 of 39987

  • HighFDA (Devices)·Z-0903-2025·2025-01-22

    Esteem Synergy Stomahesive Skin Barrier pre-cut wafers wrong size

    ConvaTec's Esteem Synergy Stomahesive Skin Barrier packages may contain pre-cut wafers of 28mm instead of the labeled 16mm or 35mm, potentially causing skin abrasion or bleeding during use.

    Product
    Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0888-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled for Potential Detector Fall Risk

    GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.

    Product
    GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0938-2025·2025-01-22

    Surgical Suction Tubes Recalled for Sterile Packaging Defects

    ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2025·2025-01-22

    Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery

    The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.

    Product
    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0901-2025·2025-01-22

    Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference

    QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2025·2025-01-22

    ECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk

    Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits should not be used.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2025·2025-01-22

    FDA Recalls Small Graptor Retractor Instruments Due to Cable Failures

    Intuitive Surgical is recalling 42,028 Small Graptor surgical retractor instruments used with da Vinci X/Xi systems due to pitch cable failures. The recalled devices affect surgical facilities nationwide and internationally.

    Product
    8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0842-2025·2025-01-22

    Augustine Temperature Management Controller Experiences Power-On Self-Test Failures

    Augustine's HOT DOG temperature management controller (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code 'EA POST' that indicates a diagnostic failure. Approximately 2,271 units have been distributed worldwide.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0923-2025·2025-01-22

    Tenaculum Forceps for da Vinci Surgical Systems Recalled Due to Pitch Cable Failures

    Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.

    Product
    8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2025·2025-01-22

    ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues

    Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2025·2025-01-22

    8MM Large Suturecut Needle Driver Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Large Suturecut Needle Driver instruments due to frayed or broken grip cables. The recall affects 784 units distributed nationwide and internationally.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0890-2025·2025-01-22

    Nuclear Medicine Systems at Risk of Detector Fall During Transport

    Certain GE Healthcare nuclear medicine systems were potentially transported without proper detector support, risking detector fall and life-threatening injury. Affected facilities should have their equipment inspected before clinical use.

    Product
    GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0941-2025·2025-01-22

    Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects

    Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2025·2025-01-22

    Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues

    Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2025·2025-01-22

    Change Healthcare Cardiology Software Defect May Cause Incorrect Medication Administration

    A software defect in Change Healthcare's Cardiology Hemodynamics software may cause clinicians to administer incorrect medications. The defect affects an autosave mechanism and has been distributed nationwide and internationally.

    Product
    Change Healthcare Cardiology Hemodynamics software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2025·2025-01-22

    ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues

    Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2025·2025-01-22

    Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.

    Product
    8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0881-2025·2025-01-22

    Intuitive Surgical Bipolar Dissector Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 8MM curved bipolar dissectors due to frayed or broken grip cables that could affect surgical instrument performance. Approximately 3,869 units were distributed nationwide and internationally.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0833-2025·2025-01-22

    Cook Medical Hiatal Hernia Graft Recalled for Documentation and Labeling Errors

    Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.

    Product
    Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0921-2025·2025-01-22

    DRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures

    DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.

    Product
    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2025·2025-01-22

    Demineralized Bone Matrix Putty Recalled for Incorrect Outer Box Expiration Date

    IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.

    Product
    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0832-2025·2025-01-22

    Biodesign Otologic Butterfly Graft Recall: Incorrect Instructions and Expiration Date

    Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.

    Product
    Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
    Category
    Medical Device
    Distribution
    2 states