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Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ
Recalled March 12, 2025 · FDA recall Z-1295-2025 · Integra LifeSciences
Hazard
Possibility for the obturator to break (separate). · FDA Class II
Units
623 units
Sold at
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.
Description
Possibility for the obturator to break (separate).
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
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →