Sutter Medizintechnik GmbH Tullastr. 87 Freiburg Im Breisgau Germany 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sutter Medizintechnik GmbH Tullastr. 87 Freiburg Im Breisgau Germany
Lot Codes / Batch Numbers
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
Products Sold
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
Sutter Medizintechnik GmbH Tullastr. 87 Freiburg Im Breisgau Germany is recalling Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. T due to 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 (. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Sutter Medizintechnik issues a recall letter via email dated July 2020. This letter instructs customers/distributors to do the following: Please further notify anyone you have distributed the product to. Please complete and return the acknowledgement and receipt form. Please exchange the IFU inside the package. You may follow the instruction as shown in the pictures. As a precautionary measure, do NOT use sharp tools such as forceps and do not perform the exchange with sharp fingernails.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026