Recall Z-1295-2025— Integra LifeSciences Corp.

Name: FDA recall Z-1295-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-06

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2025-02-06. It names one FDA 510(k) clearance: K201840. 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: Possibility for the obturator to break (separate)..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-06
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K201840 — Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics·cleared 2020-11-04

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. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

Reason for recall

Possibility for the obturator to break (separate).

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