# FDA recall Z-0507-2018

> **Microline Surgical, Inc.** · Class II · device recall initiated 2017-07-13.

## Product

The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

## Reason for recall

The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

## Distribution

Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.

## Key facts

- **Recall number:** Z-0507-2018
- **Recalling firm:** Microline Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-13
- **Report date:** 2018-02-14
- **Termination date:** 2020-02-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beverly, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2018

## Citation

> AI Analytics. FDA recall Z-0507-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0507-2018. Source: US FDA. Licensed CC0.

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