# FDA recall Z-1840-2019

> **CooperSurgical, Inc.** · Class II · device recall initiated 2019-04-23.

## Product

LEEP Precision Integrated System 120V, Model LP-10-120    Product Usage:  The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION  INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .

## Reason for recall

2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.

## Distribution

US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.

## Key facts

- **Recall number:** Z-1840-2019
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-23
- **Report date:** 2019-06-26
- **Termination date:** 2020-04-24

- **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-1840-2019

## Citation

> AI Analytics. FDA recall Z-1840-2019. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1840-2019. Source: US FDA. Licensed CC0.

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