# FDA recall Z-2427-2018

> **Covidien LLC** · Class II · device recall initiated 2018-03-15.

## Product

LigaSure" Exact Dissector Nano Coated 20.6mm-21cm    Product Usage:  A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

## Reason for recall

Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.

## Distribution

Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom

## Key facts

- **Recall number:** Z-2427-2018
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-15
- **Report date:** 2018-07-18
- **Termination date:** 2019-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2427-2018

## Citation

> AI Analytics. FDA recall Z-2427-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2427-2018. Source: US FDA. Licensed CC0.

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