Integra Lifesciences Corp. (neurosciences): Instrument, Ultrasonic Surgical

Recalling firm
Integra LifeSciences Corp. (NeuroSciences)
Product
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Reason
Software issue that renders the touch screen unresponsive.
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-06
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a7b1b8e5-7f4c-47df-9ed4-96d70a613b24