Advincula Delineator with Ultem Plastic Soft Cup size 3 — Class II medical device recall Z-1978-2019
Terminated recall by CooperSurgical, Inc., reported 2019-07-24, distributed in AZ, CA, GA, IN, LA, MA, NC, NH…. The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjecte
| Recall number | Z-1978-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2019-06-14 |
| Classified | 2019-07-15 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-05-19 |
| Distributed | AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, WA |
| Quantity | 213 units |
| Reason classes | packaging |
| Lot numbers | 021-19 |
| Model numbers | AD750SC-KE30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1978-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.