FDA Device recall Z-2744-2020
Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments
- FDA Device
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments by Sutter Medizintechnik, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2744-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-23 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Sutter Medizintechnik |
| Distribution | US |
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.
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.
Identifiers
| code_info | 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,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2744-2020%22
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