Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1977-2019 — 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 Laparoscopi

U.S. FDA — Device Enforcement · United States · 2019-06-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1977-2019
Date of alert: 2019-06-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CooperSurgical, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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