# FDA recall Z-1152-2021

> **CooperSurgical, Inc.** · Class II · device recall initiated 2021-01-21.

## Product

Milex Gellhorn Flexible under the following labels:  1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)

## Reason for recall

The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670  or 1.960  nominal height) as required. The length discrepancy does not meet the released print dimensions.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, FL, IL, KS, MA, MI, NC, NY, PA, TN, TX, WA, & Puerto Rico. The countries of New Zealand, United Kingdom.

## Key facts

- **Recall number:** Z-1152-2021
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-21
- **Report date:** 2021-03-10
- **Termination date:** 2024-01-03

- **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-1152-2021

## Citation

> AI Analytics. FDA recall Z-1152-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1152-2021. Source: US FDA. Licensed CC0.

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