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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1151–1175 of 26077

  • HighFDA (Devices)·Z-1684-2026·2026-04-08

    CPX 4 Breast Tissue Expanders with Defective Injection Needle Tips

    Mentor's CPX 4 breast tissue expanders may contain dull or blunt needle tips that could break or resist advancement during saline injection, potentially hindering treatment.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2026·2026-04-08

    Burlington Medical Leg Wraps Recalled Due to Potential Material Degradation

    Burlington Medical, LLC is recalling leg wraps with Xenolite 800 material that may degrade over time and lose effectiveness. The recall affects 103 units distributed worldwide.

    Product
    Burlington Medical, Leg Wraps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2026·2026-04-08

    da Vinci S and Si Mega Needle Driver Instruments Recalled for Broken Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver Instruments due to broken or frayed grip cables. The defect could impair surgeon control during surgical procedures.

    Product
    Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2026·2026-04-08

    Philips Allura Xper OR Table May Fail to Initiate X-Ray Imaging

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently on the Allura Xper FD20/15 OR Table when using the wired foot switch. This malfunction could impact imaging-guided surgical procedures.

    Product
    Allura Xper FD20/15 OR Table; System Code: 722059;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2026·2026-04-08

    eTRAX Needle Sensor Recall: Incorrect Position Identification Risk

    Civco Medical Instruments is recalling eTRAX Needle Sensor - 18G units due to an inspection and programming error that may cause incorrect needle tip position identification on the user interface.

    Product
    eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1747-2026·2026-04-08

    MiniMed 620G Insulin Pump Elevation Changes Cause Incorrect Insulin Delivery

    The MiniMed 620G insulin pump may deliver incorrect insulin amounts when the pump is raised or lowered relative to where it's inserted, risking severe low or high blood sugar and serious complications.

    Product
    MiniMed 620G Insulin Pump (MMT-1750)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2026·2026-04-08

    Azurion X-ray imaging system wired foot switch may fail to initiate imaging

    Philips Azurion 3 M12 X-ray systems are recalled due to wired foot switch malfunction that may prevent or interrupt X-ray imaging initiation. A total of 298 units are affected.

    Product
    Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2026·2026-04-08

    Philips Azurion 7 B20 X-ray System Foot Switch May Fail to Initiate

    Philips recalled Azurion 7 B20 X-ray systems due to foot switch malfunction that may prevent imaging initiation. Affects 1,523 units worldwide.

    Product
    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2026·2026-04-08

    FDA Recalls Burlington Medical Frontal Aprons for Potential Attenuation Degradation

    Burlington Medical recalled 14,323 frontal aprons due to potential degradation of Xenolite 800 attenuation material. The material may lose effectiveness over time, reducing protective capacity.

    Product
    Burlington Medical, Frontal Aprons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2026·2026-04-08

    Medtronic MiniMed 780G Insulin Pump Dosing Errors With Position Changes

    Medtronic recalls its MiniMed 780G insulin pump due to unintended insulin over- and under-delivery when the pump is elevated or lowered relative to the infusion site. The dosing errors can result in severe hypoglycemia or hyperglycemia.

    Product
    MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2026·2026-04-08

    MiniMed 640G Insulin Pump Incorrect Delivery Based on Pump Position

    Medtronic MiniMed 640G insulin pumps can deliver too much or too little insulin when elevated or lowered relative to the infusion site, potentially causing severe low or high blood sugar emergencies.

    Product
    MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2026·2026-04-08

    RefleXion X1 radiotherapy system software defect causes incorrect dose delivery

    The RefleXion X1 Radiotherapy System software fails to carry forward angular roll corrections into treatment delivery, potentially displacing radiation dose and causing 10-20% underdose. The recall affects 12 systems across 8 U.S. states.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1683-2026·2026-04-08

    Mentor CPX 4 Breast Tissue Expanders recalled for defective infusion needles

    Mentor Texas is recalling CPX 4 US Breast Tissue Expanders because the infusion needle sets may have dull, blunt, or broken tips that can fail during use.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2026·2026-04-08

    da Vinci Surgical Scissors Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors instruments due to increased reports of broken or frayed grip cables. These reusable surgical instruments transmit motion through cables that could malfunction during endoscopic procedures.

    Product
    Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1670-2026·2026-04-08

    Philips Allura Xper FD20/20 operating room X-ray table foot switch imaging defect

    Philips has recalled the Allura Xper FD20/20 operating room X-ray table due to wired foot switch defects that may prevent or intermittently delay X-ray imaging. Five affected units have been distributed internationally.

    Product
    Allura Xper FD20/20 OR Table; System Code: 722039;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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