Z-1295-2025 Class II Ongoing
FDA device recall Z-1295-2025 was initiated by Integra LifeSciences Corp. on February 6, 2025 and is designated Class II. Reason for recall: Possibility for the obturator to break (separate). The recall status is ongoing. Affected quantity: 623 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 623 units
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).
Distribution Pattern
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.