Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ion Flexison Biopsy Needle Recalled by Intuitive Surgical, Inc. Due to Potential for the sheath tip on the biopsy...
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 Intuitive Surgical, Inc. directly.
Affected Products
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Quantity: 1625 units
Why Was This Recalled?
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Where Was This Sold?
This product was distributed to 26 states: AZ, AR, CA, CO, FL, GA, IL, IN, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA, DC
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report