FDA Enforcement
Class II
Ongoing
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
Recall: Z-1295-2025
·
Reported March 12, 2025
Enforcement
- Recall Number
- Z-1295-2025
- Event ID
- 96216
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 12, 2025
- Initiation Date
- February 6, 2025
- Classification Date
- March 6, 2025
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650, United States
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
Possibility for the obturator to break (separate).
Code Info
Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots.
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.
Quantity
623 units