Sutter Swyng non-stick bipolar forceps — Class II medical device recall Z-2744-2020
Terminated recall by Sutter Medizintechnik GmbH, reported 2020-08-12, distributed nationwide. The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and stor
| Recall number | Z-2744-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sutter Medizintechnik GmbH, Freiburg Im Breisgau, Germany |
| Recall initiated | 2020-06-23 |
| Classified | 2020-07-31 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2020-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,337 units |
| Reason classes | chemical contamination, labeling |
| Model numbers | 105ST, 110SL, 110ST, 115SL, 115ST, 405ST, 410SL, 410ST, 415SL, 415ST, 610ST, 710ST, 810ST, 905ST, 910ST, 915ST |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2744-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.