CooperSurgical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1978-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: June 14, 2019

Date Posted: July 24, 2019

Recall Number: Z-1978-2019

Event ID: 83105

Reason for Recall:

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.

Status: Terminated

Product Quantity: 213 units in total

Code Information:

Lot 021-19

Distribution Pattern:

US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..

Voluntary or Mandated:

Voluntary: Firm initiated