FDA recall Z-1295-2025

Integra LifeSciences Corp. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-02-06
Report date
2025-03-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2025