Recall Z-2331-2024— Integra LifeSciences Corp.

Name: FDA recall Z-2331-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-07

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-06-07. It names one FDA 510(k) clearance: K232618. Product: AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.. Reason: Potential sheath damage that could lead to tissue damage and/or track hemorrhage..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-06-07
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K232618 — Aurora Surgiscope SystemRebound Therapeutics Corporation·cleared 2023-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

Reason for recall

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

Data sourced from openFDA. This site is unofficial and independent of the FDA.