medical Class II Updated 2025-03-12

Integra LifeSciences Corp. recalls AURORA Surgiscope System, Sterile, single use device that co

Recalled 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


Hazard / Issue

Possibility for the obturator to break (separate).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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.
View official government recall

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