# FDA recall Z-2137-2025

> **CooperSurgical, Inc.** · Class II · device recall initiated 2025-06-11.

## Product

Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV.    Endosee System Convenience Kit with IV Tube.

## Reason for recall

The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, 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 Washington DC.

## Key facts

- **Recall number:** Z-2137-2025
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-11
- **Report date:** 2025-07-30

- **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-2137-2025

## Citation

> AI Analytics. FDA recall Z-2137-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2137-2025. Source: US FDA. Licensed CC0.

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