AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Image...
FDA Recall #Z-1295-2025 — Class II — February 6, 2025
Product Description
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
Reason for Recall
Possibility for the obturator to break (separate).
Recalling Firm
Integra LifeSciences Corp. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
623 units
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.
Code Information
Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated