Class II

Medical Device Recall: AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

Integra LifeSciences Corp. · June 7, 2024

Reason for Recall

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Distribution

Domestic: NY, OH, & DC.

States Affected

DC, NY, OH

Quantity Affected

14 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2331-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.