Stop using nowMedical device recall · FDA · Published June 14, 2019
CooperSurgical Advincula Delineator Soft Cup Risk: Potential Cracking During Use
CooperSurgical recalls Advincula Delineator size 3.0 cm soft cups due to potential cracking from excessive compressions, which could cause lacerations during uterine procedures.
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.
Take action
Contact the company
📍Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
“CooperSurgical Advincula Delineator Soft Cup Risk: Potential Cracking During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67668-coopersurgical-advincula-delineator-soft-cup-risk-potential-cracking-during-use. Based on FDA recall #Z-1978-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1978-2019%22&limit=1).
CooperSurgical, Inc. recalled the Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm (Part No. AD750SC-KE30) on June 14, 2019, according to the FDA. The device may crack during use, potentially causing lacerations.
How to tell if you have it
Brand: CooperSurgical
Product: Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm
Part No.: AD750SC-KE30
Lot: 021-19
The hazard
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentially crack when subjected to excessive compressions during use. This failure can lead to serious health consequences, such as lacerations.
Context
GovInfoNow's records show CooperSurgical, Inc. has had 37 other recalls since October 6, 2017. Recent CooperSurgical recalls include the INCA Infant Nasal CPAP (August 11, 2026) and the Endosee System Convenience Kit (June 11, 2025). Other recent recalls of similar products include Medline Hysterectomy Kits (April 27, 2026), Medline Circumcision Kits (December 12, 2025), and Medline Breast-Hernia Port Kits (April 27, 2026).
How to tell if you have this one
Check for the product name 'Advincula Delineator' with Ultem Plastic Soft Cup size 3.0 cm. The part number is AD750SC-KE30, and it was sold with lot number 021-19.
Brand
CooperSurgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Recall number
Product, codes & lots
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 Laparoscopic Supra-Cervical Hysterectomy (LSCH).; Lot 017-19
Z-1978-2019
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).; Lot 021-19
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm if you have it.
Where it went and when
Where it was distributed
Distributed in 14 states.
Listed by the agency
Not listed
FDA distribution: “US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Georgia, Indiana, Louisiana, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Virginia, Washington.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1978-2019 (June 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1978-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.