Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System Recalled by Integra LifeSciences Corp. Due to The 36 kHz Sterilization Tray (C7136 Rev C...
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
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Quantity: 820
Why Was This Recalled?
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Where Was This Sold?
This product was distributed to 36 states: AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, PA, SC, TN, UT, VA, WA, WV, WI
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