Integra LifeSciences Corp.: Medical Device Recall in 2024 - (Recall #: Z-2331-2024)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2024.
Data Source: FDA.
Product Description:
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Product Classification:
Class II
Date Initiated: June 7, 2024
Date Posted: July 17, 2024
Recall Number: Z-2331-2024
Event ID: 94804
Reason for Recall:
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Status: Ongoing
Product Quantity: 14 units
Code Information:
Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Distribution Pattern:
Domestic: NY, OH, & DC.
Voluntary or Mandated:
Voluntary: Firm initiated