All recalls8,501 total

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella.

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Due to incorrect shelf-life expiration date.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.