All Recalls

95,050 total recalls in our database

πŸ₯ Medical Devices Class I - Dangerous

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

May 17, 2019 Other Medical Devices Nationwide View Details β†’

Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.

May 21, 2019 Diagnostic Equipment Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

May 17, 2019 Other Medical Devices Nationwide View Details β†’

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

Apr 19, 2019 Other Medical Devices Nationwide View Details β†’

There is an error in the chromomap on the package insert.

Apr 26, 2019 Other Medical Devices Nationwide View Details β†’
πŸ₯ Medical Devices Class I - Dangerous

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

May 17, 2019 Other Medical Devices Nationwide View Details β†’

may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.

Apr 26, 2019 Other Medical Devices View Details β†’

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

May 24, 2019 Other Medical Devices Nationwide View Details β†’