FDA Device recall Z-1977-2019
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm
- FDA Device
- Class II
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm by Coopersurgical, citing 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 con….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1977-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-14 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Coopersurgical |
| Distribution | AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, WA |
Product
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 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
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.
Identifiers
| code_info | Lot 017-19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2019%22
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