# FDA recall Z-0062-2019

> **Dannoritzer Medizintechnik GmbH & Co. KG** · Class III · device recall initiated 2018-08-06.

## Product

Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

## Reason for recall

The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated.  The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

## Distribution

US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.

## Key facts

- **Recall number:** Z-0062-2019
- **Recalling firm:** Dannoritzer Medizintechnik GmbH & Co. KG
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-06
- **Report date:** 2018-10-10
- **Termination date:** 2019-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tuttlingen, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0062-2019

## Citation

> AI Analytics. FDA recall Z-0062-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0062-2019. Source: US FDA. Licensed CC0.

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