The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

901–925 of 26417

  • HighFDA (Devices)·Z-1695-2026·2026-04-08

    Olympus SOLTIVE Pro Laser System power supply defect recall

    Olympus is recalling SOLTIVE Pro Laser Systems with defective 24V power supply modules that may cause device malfunction, smoke, or burning smell. 32 units distributed worldwide.

    Product
    Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2026·2026-04-08

    Medline Bronchoscopy Kits Recalled for Rubber Fragment Risk in Biopsy Valves

    Medline convenience kits containing Olympus biopsy valves are being recalled due to rubber fragments detaching from the valve slit. This could create a foreign body in a patient's airway, potentially requiring removal and causing breathing complications.

    Product
    Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2026·2026-04-08

    Sterile Radiology Procedure Kits Recalled for Potential Packaging Sterility Breach

    Medline Industries is recalling 420 units of Sterile Radiology Procedure Kits (Model DYNDH1491B, Lot 25GBB924) due to a potential breach in sterile pouch packaging that may compromise product sterility.

    Product
    Sterile Radiology Procedure Kits, Model Number DYNDH1491B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2026·2026-04-08

    Finesse BTK Multicath Balloon Catheter Recalled for Burst Specification Risk

    SUMMA THERAPEUTICS recalled the Finesse BTK Multicath balloon catheter due to the potential that the balloon may not meet burst specifications. The recall affects 22 units in New Jersey and Florida.

    Product
    Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2026·2026-04-08

    da Vinci Grasper Instruments Recalled for Broken or Frayed Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments due to increased complaints of broken or frayed grip cables.

    Product
    Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including bl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2026·2026-04-08

    Burlington Medical Thyroid Shield: Potential Attenuation Material Degradation

    Burlington Medical thyroid shields manufactured with Xenolite 800 material from January 16, 2025 to January 21, 2026 may experience degradation of their radiation-shielding capability over time. The recall affects approximately 41,962 units distributed worldwide.

    Product
    Burlington Medical, Thyroid Shield.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2026·2026-04-08

    Medtronic MiniMed 770G Insulin Pump May Deliver Incorrect Insulin Doses

    The FDA is recalling the Medtronic MiniMed 770G insulin pump due to a defect that can cause over- or under-delivery of insulin when the pump position changes relative to the infusion site. This can result in severe low or high blood sugar, potentially causing seizures, coma, or death.

    Product
    MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1662-2026·2026-04-08

    X-ray imaging system may not initiate or may malfunction due to foot switch defect

    The Philips ALLURA Xper FD10/10 X-ray system may fail to initiate or operate intermittently when using its wired foot switch. Approximately 112 affected units have been distributed in the United States and internationally.

    Product
    ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2026·2026-04-08

    Philips ALLURA surgical X-ray table foot switch imaging failure

    Philips has issued a Class II recall for its ALLURA Xper FD10 operating table due to a wired foot switch defect that may prevent X-ray imaging from initiating or cause intermittent operation.

    Product
    ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2026·2026-04-08

    Medline Biopsy Valve Kits Recalled for Risk of Rubber Fragment Detachment

    Medline has recalled 14,379 biopsy valve kits due to complaints about rubber fragments detaching from the valve slit. These fragments could lodge in a patient's airway and may require removal intervention.

    Product
    Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2026·2026-04-08

    da Vinci Surgical Forceps Instrument Recalled Due to Frayed or Broken Cables

    Intuitive Surgical is recalling 2,095 da Vinci S and Si Tenaculum Forceps Instruments due to increased complaints of frayed or broken pitch cables that could impair instrument function during surgery.

    Product
    Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp end
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2026·2026-04-08

    Burlington Medical BAT Coverage Recalled for Potential Attenuation Material Degradation

    Burlington Medical is recalling BAT (Breast, Axilla and Thyroid) Coverage protective devices due to potential degradation of the attenuation material over time, which may reduce their protective lifespan.

    Product
    Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2026·2026-04-08

    FDA Recalls Paradise Ultrasound Renal Denervation Catheter Due to Nonconformance

    ReCor Medical is recalling the Paradise® Ultrasound Renal Denervation System catheter because a nonconforming product was distributed that should have been scrapped and was not intended for human use.

    Product
    Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2026·2026-04-08

    Vue Motion cardiac imaging system may display frames out of sequence

    The Vue Motion V12 cardiac imaging system may display image frames out of sequence during dynamic cine runs. Philips Medical Systems is recalling 3,552 units worldwide due to this potential defect.

    Product
    Vue Motion V12. Product Number: 1017979.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2026·2026-04-08

    Medtronic MiniMed 700G Insulin Pump Recalled for Elevation-Dependent Delivery Errors

    Medtronic's MiniMed 700G Insulin Pump malfunctions when elevated or lowered relative to the infusion site, causing unintended insulin over- or under-delivery, which can lead to severe hypoglycemia or hyperglycemia.

    Product
    MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2026·2026-04-08

    Medline Anterior Hip Pack with defective biopsy valves recalled

    Medline is recalling hip surgery kits containing Olympus biopsy valves with a defect that can cause rubber fragments to detach. These fragments pose a risk of lodging in the patient's airway.

    Product
    MEDLINE ANTERIOR HIP PACK DYNJ64672B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2026·2026-04-08

    Surgical Screw with Incorrect Threading Recalled Due to Manufacturing Error

    Synthes (USA) Products LLC is recalling a surgical screw product due to a manufacturing error where units received incorrect threading. The affected lot may pose a risk if used in orthopedic surgery.

    Product
    2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2026·2026-04-08

    Philips Azurion 7 B12 X-ray system wired foot switch malfunction recall

    Philips is recalling Azurion 7 B12 X-ray imaging systems due to a wired foot switch defect that may prevent or cause intermittent X-ray image initiation.

    Product
    Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2026·2026-04-08

    Medtronic MiniMed 670G Insulin Pump Dosing Defect

    Medtronic MiniMed 670G insulin pumps have a defect that may cause over- or under-delivery of insulin based on pump position relative to the infusion site. This can lead to dangerously high or low blood sugar levels.

    Product
    MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0420-2026·2026-04-08

    Prazosin Hydrochloride Capsules Recalled for Nitrosamine Impurity Above Limits

    Appco Pharma LLC is recalling Prazosin Hydrochloride 2mg capsules due to detection of N-nitroso-prazosin impurity above acceptable limits. The recall covers 58,896 bottles distributed nationwide.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0414-2026·2026-04-08

    Eye drops recalled for lack of sterility assurance

    K.C. Pharmaceuticals recalls multiple brands of over-the-counter eye drops nationwide due to lack of assurance of sterility. Approximately 315,144 bottles are affected.

    Product
    GNP EYE DROPS REDNESS AND DRY EYE RELIEF — GNP EYE DROPS REDNESS AND DRY EYE RELIEF (GLYCERIN, NAPHAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2026·2026-04-08

    MRI scanners with ferrous fittings pose magnetic hazard during service

    GE Healthcare SIGNA Premier MRI scanners may have ferrous steel fittings instead of brass on the magnet rear. During servicing with the magnet powered, technicians could be injured if these fittings are attracted to the magnetic field.

    Product
    SIGNA Premier systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0409-2026·2026-04-08

    Quality Choice Eye Drops Recalled for Manufacturing Sterility Defect

    K.C. Pharmaceuticals is recalling 182,424 bottles of Quality Choice and store-brand eye drops nationwide due to lack of sterility assurance in manufacturing. Affected bottles expire May 31, 2026.

    Product
    QUALITY CHOICE EYE DROPS IRRITATION RELIEF — QUALITY CHOICE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide