# FDA recall Z-3278-2018

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

## Product

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG)    Product Usage:  The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

## Reason for recall

There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

## Distribution

Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the  following foreign countries of:  Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.

## Key facts

- **Recall number:** Z-3278-2018
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-04
- **Report date:** 2018-10-03
- **Termination date:** 2020-04-15

- **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-3278-2018

## Citation

> AI Analytics. FDA recall Z-3278-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3278-2018. Source: US FDA. Licensed CC0.

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