Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm Recalled by CooperSurgical, Inc. Due to The soft, flexible cup of the Advincula Delineator...
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 CooperSurgical, Inc. directly.
Affected Products
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).
Quantity: 213 units in total
Why Was This Recalled?
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
Where Was This Sold?
This product was distributed to 14 states: AZ, CA, GA, IN, LA, MA, NH, NJ, NY, NC, OH, PA, VA, WA
About CooperSurgical, Inc.
CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report