FDA recall, , Moderate risk
Integra LifeSciences CUSA Clarity C7000 Console
The CUSA Clarity C7000 Console has a software issue that renders the touch screen unresponsive.
Summary by Recall Canary from the FDA notice
What happened
Integra LifeSciences Corp. (NeuroSciences) of Princeton, New Jersey recalled 78 units of the CUSA Clarity C7000 Console, Software Version 2.1.1.909, an ultrasonic surgical aspirator system, because of a software issue that renders the touch screen unresponsive. The recall began March 6, 2026 and was added to the FDA's Enforcement Report on April 17, 2026.
The product was distributed worldwide, including nationwide in the US states of Michigan and New York, and in Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Poland, Spain, Switzerland, Tunisia and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
- UDI-DI
- 10381780126232
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Michigan & New York. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.
- Company
- Integra LifeSciences Corp. (NeuroSciences)Princeton, New Jersey
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98476
- Recall number
- Z-1828-2026
- Quantity recalled
- 78 units
All recalls from Integra LifeSciences Corp. (NeuroSciences)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
