FDA Medical Device Recalls (openFDA)
Sutter Medizintechnik GmbH: 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 number
- Z-2744-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-06-23
- Posted
- not on file
- Terminated
- 2020-08-21
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K193587"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004857377
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28