# FDA recall Z-1957-2019

> **Richard Wolf Medical Instruments Corp.** · Class II · device recall initiated 2019-05-23.

## Product

E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile.  One electrode is placed in a plastic tray and then inserted into a Tyvek pouch.  Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

## Reason for recall

E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

## Distribution

US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.

## Key facts

- **Recall number:** Z-1957-2019
- **Recalling firm:** Richard Wolf Medical Instruments Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-23
- **Report date:** 2019-07-17
- **Termination date:** 2020-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vernon Hills, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2019

## Citation

> AI Analytics. FDA recall Z-1957-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1957-2019. Source: US FDA. Licensed CC0.

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