CooperSurgical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1686-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

Product Classification:

Class II

Date Initiated: April 23, 2021

Date Posted: June 2, 2021

Recall Number: Z-1686-2021

Event ID: 87849

Reason for Recall:

The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.

Status: Ongoing

Product Quantity: 6 boxes or 12 units

Code Information:

Lot 280819

Distribution Pattern:

Domestic: UT, OH, DE

Voluntary or Mandated:

Voluntary: Firm initiated