Z-1977-2019Class II

Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator...

Name: Z-1977-2019 Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator...
Creator: CooperSurgical, Inc.
Published: 2019-06-14
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2019-06-14 / Terminated

FDA source

CooperSurgical, Inc. began a recall of 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... on 2019-06-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1977-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-14
Posted: 2019-07-15
Terminated: 2020-05-19
Recalling firm: CooperSurgical, Inc.
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).
Product code: HEW Culdoscope (And Accessories)
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.
FDA root cause: Under Investigation by firm
Action: 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: [email protected] 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.
Quantity in commerce: 213 units in total
Distribution: US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Product codes and lots: Lot 017-19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1977-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1977-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-15
Z-1978-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-15

Product code HEW

K180429Class IIAdvincula Delineator Uterine ManipulatorCooperSurgical, Inc. / cleared 2018-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)