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.

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2501–2525 of 13381

  • LowFDA (Devices)·Z-2389-2025·2025-09-03

    S12-4 Transducer Probe Labeling Clarification for Useful Life Definition

    Philips recalls 171,322 units of the S12-4 Transducer Probe to provide clarification and updated labeling that defines the useful life of ultrasound transducers in field use.

    Product
    S12-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2407-2025·2025-09-03

    Philips X3-1 Transducer Probe: Clarification on Useful Life Labeling

    Philips is recalling 171,322 X3-1 Transducer Probe units nationwide to provide clarified labeling defining the ultrasound transducers' useful life.

    Product
    X3-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2400-2025·2025-09-03

    Philips Ultrasound Transducer Probe Labeling Clarification on Useful Life

    Philips Ultrasound is clarifying labeling on the SCNHD LA L7-4 HDI Transducer Probe to better define useful life. The clarification affects approximately 171,322 units distributed nationwide.

    Product
    SCNHD LA L7-4 HDI Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2360-2025·2025-09-03

    C9-2 Ultrasound Transducer Probe Useful Life Labeling Clarification

    Philips Ultrasound recalls 171,322 C9-2 Transducer Probe units to provide clarification and labeling defining the useful life of these medical ultrasound transducers. No illnesses or injuries have been reported.

    Product
    C9-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2361-2025·2025-09-03

    Philips C9-3io Transducer Probe Useful Life Labeling Clarification

    Philips Ultrasound is recalling 171,322 units of the C9-3io Transducer Probe to provide clarification and labeling regarding the useful life of the devices. Units were distributed nationwide in the United States.

    Product
    C9-3io Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2327-2025·2025-08-27

    Defibrillator leads recalled for calcification risk and potential device failure

    Multiple models of RELIANCE 4-FRONT defibrillator leads may develop calcification, leading to device failure and potential cardiac emergencies.

    Product
    RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2326-2025·2025-08-27

    Defibrillation lead recalled due to calcification and device failure

    Boston Scientific recalls ENDOTAK RELIANCE defibrillation leads that may calcify over time, potentially requiring early replacement and posing cardiac risk.

    Product
    ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2325-2025·2025-08-27

    Defibrillation Leads Risk Early Replacement From Coil Calcification

    Boston Scientific's ENDOTAK RELIANCE defibrillation leads may develop coil calcification causing gradually rising electrical impedance measurements. This condition may require early lead replacement; most serious outcomes include cardiac emergency or death.

    Product
    ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2328-2025·2025-08-27

    Hamilton C6 Ventilator Recalled Due to Mechanical Circuit Board Defect

    Hamilton Medical is recalling 1,040 Hamilton C6 ventilators nationwide due to a mechanical defect in the printed circuit board that may cause device failure or interruption of ventilation.

    Product
    Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2025·2025-08-27

    OtoLase Surgical Laser Starter Kit Recalled for Potential Sterilization Failure

    Lumenis recalls OtoLase Starter Kit surgical lasers due to potential sterilization failures. Units may be unsterilized despite sterile labeling, creating infection risk.

    Product
    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2335-2025·2025-08-27

    Medical device chemistry slides recalled for increased calibration failures

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry calcium test slides that experience frequent calibration failures, potentially delaying diagnosis of serious calcium-related emergencies. A 19-fold increase in failure rates was documented in 2025 compared to 2024 baseline.

    Product
    VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2025·2025-08-27

    Burr Hole Cover Kit Recall Due to Retaining Clip Closure Difficulty

    Boston Scientific is recalling Burr Hole Cover Kits used in Vercise Deep Brain Stimulation systems. The retaining clip locking mechanism may be difficult to close during surgery, potentially causing procedural delays or requiring additional surgery.

    Product
    Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2025·2025-08-27

    Spiggle & Theis Injection Needles Recalled Due to Cytotoxicity Risk

    Spiggle & Theis Mt Gmbh is recalling two models of injection needles due to elevated cytotoxicity values that may cause allergic or intolerance reactions. The affected products were distributed in California, Connecticut, Missouri, and Ohio.

    Product
    Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2025·2025-08-27

    Estrone RIA Diagnostic Kit Recalled for Potentially Inaccurate Test Results

    Immunotech is recalling 279 units of the Estrone RIA diagnostic kit due to rare instances where test results may be falsely high or low, which might cause temporary or permanent injury.

    Product
    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2025·2025-08-27

    ESG-410 Electrosurgical Generator Recalled for System Error and Reboot Malfunction

    The Olympus ESG-410 Electrosurgical Generator may display an E0662 system error and reboot unexpectedly. The FDA Class II recall affects 155 units distributed nationwide, with specific serial numbers listed in the recall notice.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2025·2025-08-27

    Electrosurgical Generator ESG-410 Recalled for System Error and Reboot Malfunctions

    Olympus ESG-410 Electrosurgical Generators may display a system error and reboot or enter continuous reboot loops during use. This could interrupt surgical procedures.

    Product
    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2025·2025-08-27

    Video Processor May Cause Thermal Injury During Endoscopic Procedures

    Pentax Medical Video Processor Model EPK-i8020c may overheat during endoscopic procedures, causing the light guide tip to become hot and risk thermal injury to patient tissues.

    Product
    Pentax Medical Video Processor; Model Number: EPK-i8020c;
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2330-2025·2025-08-27

    DRS Vascular Q-Stop Suture Retention Device Class II Recall

    Drs Vascular, Inc. has issued a voluntary recall of 264 units of DRS Vascular Q-Stop Suture Retention Devices distributed nationwide in Arkansas, California, and New York.

    Product
    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installe
    Category
    Medical Device
    Distribution
    Distributed nationwide