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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Integra CUSA Clarity C7000 Console Recalled for Unresponsive Touch Screen

Agency Publication Date: April 17, 2026
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Summary

Integra LifeSciences is recalling 78 units of the CUSA Clarity C7000 Console (Software Version 2.1.1.909), an ultrasonic surgical aspirator system used in neurosurgery. A software issue can cause the touch screen to become unresponsive, which may disrupt critical surgical procedures. While no injuries have been reported, this device is used in high-stakes medical environments and requires immediate attention.

Risk

The software defect renders the touch screen non-functional, preventing surgeons from adjusting settings or controlling the device during surgery. This could lead to surgical delays or the inability to safely complete a procedure.

What You Should Do

  1. Stop using the recalled CUSA Clarity C7000 Console immediately.
  2. Identify your device by checking the Model (C7000), UDI (10381780126232), and the serial number on the device label. See the Affected Products section below for the full list of affected codes.
  3. Contact Integra LifeSciences Corp. or your authorized medical distributor to arrange for a software correction, device return, or replacement.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CUSA Clarity C7000 Console, Software Version: 2.1.1.909
Variants: Ultrasonic surgical aspirator system
Model / REF:
C7000
Serial Numbers (78):
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
UDI:
10381780126232

Software Version: 2.1.1.909

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98476
Status: Active
Manufacturer: Integra LifeSciences Corp. (NeuroSciences)
Sold By: Authorized Medical Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 78
Distributed To: Michigan, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.