All recalls8,424 total

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.

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.

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

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

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.

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

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

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

Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.

Assayed Whole blood control contains labeling with incorrect performance range.

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

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

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Due to an increase rate of balloon pinhole defects.