Class II

Medical Device Recall: AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

Integra LifeSciences Corp. · February 6, 2025

Reason for Recall

Possibility for the obturator to break (separate).

Distribution

US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.

States Affected

NATIONWIDE

Quantity Affected

623 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1295-2025

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.

Integra LifeSciences Corp. Medical Device Recall: AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80 | SafeCheck