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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9026–9050 of 27637

  • HighFDA (Devices)·Z-0918-2025·2025-01-22

    Portrait Core Services Software Loss of Patient Monitoring After 425 Days

    A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.

    Product
    Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2025·2025-01-22

    Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling 512,786 Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2025·2025-01-22

    Intuitive Surgical Needle Driver Recall Due to Grip Cable Failures

    Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0838-2025·2025-01-22

    NOA Medical Industries Hospital Bed Side Rails Recalled for Defective Engagement Button

    NOA Medical Industries is recalling 34 hospital bed side rails (Model 1055050GRY-BOX) because the red button used to engage the rails can break or become stuck, making it difficult to engage the safety rails.

    Product
    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0837-2025·2025-01-22

    Karl Storz Biopsy and Grasping Forceps Recalled Due to Sterility Validation Failure

    Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.

    Product
    Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0853-2025·2025-01-22

    Surgical Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.

    Product
    8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0201-2025·2025-01-22

    Clobazam tablets recalled for contamination with foreign tablets

    Amerisource Health Services LLC is recalling Clobazam 10 mg tablets nationwide due to contamination with foreign tablets or capsules. Patients should contact their pharmacist or healthcare provider.

    Product
    CLOBAZAM — CLOBAZAM (CLOBAZAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2025·2025-01-22

    Surgical Kit Recall: Potential Endotoxin Contamination in Cardinal Health Presource Kits

    Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2025·2025-01-22

    Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk

    Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.

    Product
    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2025·2025-01-22

    Surgical Retractor Grip Cables May Fray or Break During Use

    Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.

    Product
    8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0848-2025·2025-01-22

    Surgical Scissors Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance during surgical procedures.

    Product
    8MM, POTTS SCISSORS, IS4000 REF 470001
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0843-2025·2025-01-22

    Augustine Temperature Management Controllers May Fail Startup Self-Test

    Augustine Surgical's veterinary temperature management controllers may experience a power-on self-test error during startup. Approximately 1,113 units have been distributed worldwide.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0882-2025·2025-01-22

    Intuitive Surgical Bipolar Grasper Recall Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.

    Product
    8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0845-2025·2025-01-22

    X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect

    Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.

    Product
    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
    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-0906-2025·2025-01-22

    BD Pyxis MedStation ES software issue may delay medication dispensing

    A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.

    Product
    BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
    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-0896-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled Due to Detector Fall Risk

    GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.

    Product
    GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0953-2025·2025-01-22

    ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk

    Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2025·2025-01-22

    Intuitive Surgical Bipolar Dissectors Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0869-2025·2025-01-22

    Intuitive Surgical Fenestrated Grasper Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.

    Product
    8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0856-2025·2025-01-22

    8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0844-2025·2025-01-22

    Folysil Silicone Foley Catheters Recalled for Possible Sterility Issue

    Coloplast recalls Folysil Silicone Foley Catheters due to a possible sterility defect detected at the manufacturing facility. The affected units may not maintain proper sterilization, posing a risk of infection.

    Product
    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA642
    Category
    Medical Device
    Distribution
    Distributed nationwide