# FDA recall Z-2112-2020

> **CooperSurgical, Inc.** · Class II · device recall initiated 2020-04-09.

## Product

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

## Reason for recall

The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

## Distribution

Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI

## Key facts

- **Recall number:** Z-2112-2020
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-09
- **Report date:** 2020-06-03
- **Termination date:** 2021-05-11

- **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-2112-2020

## Citation

> AI Analytics. FDA recall Z-2112-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2112-2020. Source: US FDA. Licensed CC0.

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