🏥 Medical Devices • 6,839 recalls
Degania Medical Devices Pvt.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Degania Medical Devices Pvt.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Acutus Medical
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Degania Medical Devices Pvt.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Degania Medical Devices Pvt.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Degania Medical Devices Pvt.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Degania Medical Devices Pvt.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.
Smiths Medical ASD
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
The retaining ring on the neck trials has a potential to fail interoperatively.
Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Sterility compromised due to packaging pouches that may not be sealed properly
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.