# FDA recall Z-2744-2020

> **Sutter Medizintechnik GmbH** · Class II · device recall initiated 2020-06-23.

## Product

Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

## Reason for recall

The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.

## Distribution

US Nationwide distribution including in the states of MD, NJ, MI, NC, IN, CA, AL, WA, OK, MS, GA, FL, SC, TX, CO, MN, MO, KS.

## Key facts

- **Recall number:** Z-2744-2020
- **Recalling firm:** Sutter Medizintechnik GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-23
- **Report date:** 2020-08-12
- **Termination date:** 2020-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2744-2020

## Citation

> AI Analytics. FDA recall Z-2744-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2744-2020. Source: US FDA. Licensed CC0.

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