# FDA recall Z-0798-2020

> **CooperSurgical, Inc.** · Class II · device recall initiated 2019-12-13.

## Product

ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5    The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

## Reason for recall

Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).

## Distribution

US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY.    OUS: None

## Key facts

- **Recall number:** Z-0798-2020
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-13
- **Report date:** 2020-01-22
- **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-0798-2020

## Citation

> AI Analytics. FDA recall Z-0798-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0798-2020. Source: US FDA. Licensed CC0.

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