DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall
Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.
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 involves a corrective action to instructions for use, which is a documentation/labeling issue. The source text does not report any illnesses, injuries, or confirmed harms, making this a precautionary measure consistent with FDA Class II classification.
Plain-English summary
Katalyst Surgical, LLC is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number DVF4034-25. The corrective action concerns the instructions for use (IFU) for DEX Forceps and Scissors.
Approximately 750 units have been distributed worldwide, including throughout the US and to Peru, Argentina, South Korea, Japan, and France. Multiple lot numbers are affected, with expiration dates ranging from April 2028 through February 2029.
Patients and healthcare providers who have received this device should refer to the corrected instructions. For questions or more information, contact Katalyst Surgical, LLC or the FDA.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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