Sutter Medizintechnik GmbH: Medical Device Recall in 2020 - (Recall #: Z-2744-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 23, 2020

Date Posted: August 12, 2020

Recall Number: Z-2744-2020

Event ID: 86035

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.

Status: Terminated

Product Quantity: 1337 units

Code Information:

Models: 78 44 905 ST, 78 44 105 ST, 78 44 405 ST, 78 44 910 ST, 78 44 110 ST, 78 44 410 ST, 78 44 915 ST, 78 44 115 ST, 78 44 415 ST, 78 44 710 ST, 78 44 610 ST, 78 44 810 ST, 78 44 110 SL, 78 44 410 SL, 78 44 115 SL, 78 44 415 SL

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated