CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Summary
The FDA issued a Class II for CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical asp by Integra LifeSciences Corp. (NeuroSciences). Reason: Software issue that renders the touch screen unresponsive..
Details
Source
Device Recall
External ID
Z-1828-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Lot/Code Info: Model: C7000; UDI: 10381780126232; Serial Numbers: CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE, CHA2305401IE, CHA2307001IE, CHA2402201IE, CHB1711001IE, CHB1723601IE, CHB2000801IE, CHB2100901IE, CHB2301401IE, CHB2500101IE, CHC1800601IE, CHC1902601IE, CHC1902701IE, CHC2001201IE, CHD1705801IE, CHD1707101IE, CHD1801001IE, CHD1801101IE, CHD1902501IE , CHE1707201IE, CHE1707301IE, CHE2203301IE, CHE2204001IE, CHE2301001IE , CHE2305001IE, CHE2502901IE, CHE2503101IE, CHE2503201IE, CHE2503401IE, CHE2503701IE, CHF1701401IE, CHF1702701IE, CHF2100701IE, CHF2303701IE, CHF2305401IE, CHG1700101IE, CHG1700801IE, CHG1902401IE, CHG2000201IE, CHG2000301IE, CHG2204101IE, CHG2402301IE, CHG2502801IE, CHG2506001IE, CHH1802901IE, CHH2402801IE, CHH2500601IE, CHJ2001101IE, CHJ2001301IE , CHJ2301201IE, CHJ2304601IE, CHK1700801IE, CHK1702301IE, CHK1703001IE, CHK2402601IE, CHK2403401IE, CHK2404101IE, CHL1701701IE, CHL1900201IE, CHL2102901IE , CHL2103001IE, CHL2301301IE, CHL2302001IE, CHL2302101IE, CHL2403301IE, CHM1901901IE, CHM2100101IE, CHM2101601IE, CHM2200201IE, CHM2200301IE, CHM2200501IE, CHM2300701IE, CHM2402101IE.
Quantity Affected: 78 units
Reason for Recall
Software issue that renders the touch screen unresponsive.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-06
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 217 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp. (NeuroSciences)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. (NeuroSciences) have FDA actions?
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1828-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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