Warning
Integra LifeSciences Corp. (NeuroSciences) Recalls CUSA Clarity C7000 Console, Software Version: 2.1.1.909
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1828-2026Medical Device
Integra LifeSciences Corp. (NeuroSciences) Recalls CUSA Clarity C7000 Console, Software Version: 2.1.1.909
Integra LifeSciences Corp. (NeuroSciences) · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Integra LifeSciences Corp. (NeuroSciences) has recalled a medical device that the FDA classified as Class II affecting 78 units. The recall was initiated on March 6, 2026. Software issue that renders the touch screen unresponsive. It was distributed internationally, including the United States. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.