Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The Recalled by Integra LifeSciences Corp. Due to There is a potential for erosion of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected Products
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Quantity: USA 6,190, EU 22,972 and ROW 288 units
Why Was This Recalled?
There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
Where Was This Sold?
Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa.
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report