Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TruDi NAV Suction Recalled by Integra LifeSciences Corp. Due to Specific lots of TruDi NAV Suction Instruments 0...
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
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Quantity: 265 units
Why Was This Recalled?
Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
Where Was This Sold?
This product was distributed to 35 states: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, ND, OH, PA, SC, SD, TN, TX, VT, VA, 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