# FDA recall Z-0098-2019

> **CooperSurgical, Inc.** · Class II · device recall initiated 2018-09-04.

## Product

Colpo-Pneumo Occluder, Part CPO-6

## Reason for recall

The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

## Distribution

The products were distributed to the following US states:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.    The products were distributed to the following foreign countries:  Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.

## Key facts

- **Recall number:** Z-0098-2019
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-04
- **Report date:** 2018-10-17
- **Termination date:** 2020-05-27

- **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-0098-2019

## Citation

> AI Analytics. FDA recall Z-0098-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0098-2019. Source: US FDA. Licensed CC0.

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