Recall Z-1828-2026— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1828-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-06

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2026-03-06. It names one FDA 510(k) clearance: K161882. Product: CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.. Reason: Software issue that renders the touch screen unresponsive..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class II
Status: Ongoing
Initiated: 2026-03-06
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K161882 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation·cleared 2016-10-14

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

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Reason for recall

Software issue that renders the touch screen unresponsive.

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