Medical Devices Recalls

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Lidstock states the incorrect expiration date for the product

Lidstock states the incorrect expiration date for the product

Lidstock states the incorrect expiration date for the product

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.

Lidstock states the incorrect expiration date for the product

Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Lidstock states the incorrect expiration date for the product

Lidstock states the incorrect expiration date for the product

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

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

Lidstock states the incorrect expiration date for the product

Lidstock states the incorrect expiration date for the product

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.

The bearings of the saw attachments were ungreased.

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.

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.

Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.

Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.