CooperSurgical, Inc. 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
Lot 017-19
Products Sold
Lot 017-19
CooperSurgical, Inc. is recalling Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula due to The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On June 14, 2019, the firm, CooperSurgical, notified customers of the recall via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were informed that the soft, flexible cup of the Advincula Delineator may crack when subjected to excessive compression during use. The failure mode could lead to serious health consequences such as lacerations. Customers are asked to do the following; - Quarantine affected products - Complete the enclosed Acknowledgement and Receipt form and return to Cooper Surgical via email: recall@coopersurgical.com or fax to 203.601.9870 ATTN: Product Surveillance, even if you do not have affected product. - Once the firm has received your acknowledgement form, it will arrange for product returns and replacements, if requested. If you have questions regarding this recall, you may contact the firm at 2036015200 ext. 3300.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, IN, LA, MA, NH, NJ, NY, NC, OH, PA, VA, WA
Page updated: Jan 10, 2026