Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Ultem Polymeric Resin Koh Cup is a non- sterile Recalled by CooperSurgical, Inc. Due to The affected Koh Cup were incorrectly packaged with...

Date: April 23, 2021
Company: CooperSurgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.

Affected Products

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

Quantity: 6 boxes or 12 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: DE, OH, UT

Affected (3 states)Not affected

About CooperSurgical, Inc.

CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report