Sutter Swyng Non-Stick Bipolar Forceps Recalled for Incorrect Package Insert Labeling
Sutter Medizintechnik GmbH is recalling 1,337 units of Sutter Swyng non-stick bipolar forceps because the package insert incorrectly displays the Ethylene Oxide sterilization symbol instead of the irradiation symbol.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a minor labeling error on the package insert regarding sterilization symbols without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Sutter Medizintechnik GmbH is recalling 1,337 units of Sutter Swyng non-stick bipolar forceps. These are single-use electrosurgical instruments provided with a bayonet-style handle design and various tip configurations. The products were distributed nationwide in the United States, including in Maryland, New Jersey, Michigan, North Carolina, Indiana, California, Alabama, Washington, Oklahoma, Mississippi, Georgia, Florida, South Carolina, Texas, Colorado, Minnesota, Missouri, and Kansas.
The recall is due to a labeling error on the package insert (Instructions for Use). While the cardbox and blister packaging correctly display the symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert incorrectly shows the symbol for sterilization using Ethylene Oxide alongside the description for sterilization using irradiation.
Healthcare providers and consumers should stop using the affected forceps and contact Sutter Medizintechnik GmbH for instructions on return or replacement. The affected models include 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, and 78 44 415 SL.
The recalled product
- 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
- Manufacturer
- Sutter Medizintechnik GmbH
- Hazard
- Affected units
- 1,337
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distribution
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