# FDA recall Z-1978-2019

> **CooperSurgical, Inc.** · Class II · device recall initiated 2019-06-14.

## Product

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).

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1978-2019
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-14
- **Report date:** 2019-07-24
- **Termination date:** 2020-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1978-2019

## Citation

> AI Analytics. FDA recall Z-1978-2019. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1978-2019. Source: US FDA. Licensed CC0.

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