Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re Recalled by Sutter Medizintechnik GmbH Due to The label on the cardbox and the blister...

Date: June 23, 2020
Company: Sutter Medizintechnik GmbH
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sutter Medizintechnik GmbH directly.

Affected Products

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.

Quantity: 1337 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sutter Medizintechnik GmbH

Sutter Medizintechnik GmbH has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report