HIGH
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
Integra LifeSciences Corp.
Increased rate
HIGH
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Software issue that renders the touch screen unresponsive.
Quick Facts at a Glance
- Recall Date
- March 6, 2026
- Hazard Level
- HIGH
- Brand
- Integra LifeSciences Corp.
- Geographic Scope
- 1 states
Hazard Information
Software issue that renders the touch screen unresponsive.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider for instructions. Notification method: Letter
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Full Description
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.. Reason: Software issue that renders the touch screen unresponsive.. Classification: Class II. Quantity: 78 units. 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.
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Product Classification
Product Details
Categories
Model Numbers
Model: C7000
UDI: 10381780126232
Serial Numbers: CHA1902101IE
CHA2001301IE
CHA2001401IE
+15 more
Affected States
ALL
Report Date
April 29, 2026
Source Agency
FDA - Medical DevicesRecall Status
ACTIVE
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