CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Sutter Swyng non-stick bipolar forceps recalled by Sutter Medizintechnik
Sutter Medizintechnik is recalling Sutter Swyng non-stick bipolar forceps, distributed nationwide in the US. The recall was initiated on 23 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2744-2020
- FDA event ID
- 86035
- Recalling firm
- Sutter Medizintechnik, Freiburg Im Breisgau
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2020
- FDA classified
- 31 Jul 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 23 Jun 2020 | Recall initiated by company | |
| 31 Jul 2020 | Classified by FDA | +38 days |
| 12 Aug 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaCaliforniaColoradoFloridaGeorgiaIndianaKansasMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNew JerseyOklahomaSouth CarolinaTexasWashington
Questions about this recall
Is Sutter Swyng non-stick bipolar forceps recalled?
Yes. Sutter Medizintechnik recalled Sutter Swyng non-stick bipolar forceps on 23 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2744-2020.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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