Medical device recalls Moderate risk

Integra LifeSciences Corp. (NeuroSciences) recalls CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Recall date
March 6, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1828-2026
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp. (NeuroSciences)
Sold / distributed
Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.

Why it was recalled

Software issue that renders the touch screen unresponsive.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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