# FDA recall Z-1686-2021

> **CooperSurgical, Inc.** · Class II · device recall initiated 2021-04-23.

## Product

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

## 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.

## Distribution

Domestic: UT, OH, DE

## Key facts

- **Recall number:** Z-1686-2021
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-23
- **Report date:** 2021-06-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2021

## Citation

> AI Analytics. FDA recall Z-1686-2021. Retrieved 2026-07-29 from https://api.ai-analytics.org/recall/Z-1686-2021. Source: US FDA. Licensed CC0.

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