Z-2744-2020Class II

Sutter Swyng non-stick bipolar forceps -

Name: Z-2744-2020 Sutter Swyng non-stick bipolar forceps -
Creator: Sutter Medizintechnik GmbH
Published: 2020-06-23
License: https://open.fda.gov/license/

Sutter Medizintechnik GmbH / initiated 2020-06-23 / Terminated / root cause: labeling and UDI

FDA source

Sutter Medizintechnik GmbH began a recall of Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle... on 2020-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2744-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-23
Posted: 2020-07-31
Terminated: 2020-08-21
Recalling firm: Sutter Medizintechnik GmbH
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 1337 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2744-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2744-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-07-31

Product code GEI

K193587Class IISutter Swyng non-stick bipolar forceps, single-useSutter Medizintechnik GmbH / cleared 2020-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)