DEX Ophthalmic Tissue Forceps recalled for instruction updates
Katalyst Surgical is issuing a Field Safety Corrective Action for 670 units of DEX Ophthalmic Tissue Forceps (Model DVF4019-25) due to updates required in the instructions for use. The device was distributed worldwide.
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: This is an FDA Class II recall involving a corrective action to update instructions for use. No hospitalization reports, illnesses, injuries, or specific hazard consequences are stated in the source text, and the action is a precautionary update to instructional documentation.
Plain-English summary
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for the DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps (Model/Catalog Number DVF4019-25). A total of 670 units have been affected. This action involves corrective updates to the Instructions for Use (IFU) for DEX Forceps and Scissors.
The affected devices were distributed worldwide, including to the United States and internationally to Peru, Argentina, South Korea, Japan, and France. Multiple lot numbers are included in this recall, spanning from lot M49164 (expiration 08/06/2028) through lot M51588 (expiration 12/12/2028).
Health care providers and facilities that received these devices should implement the corrective action and updated instructions for use. For more information or questions regarding this recall, contact the manufacturer or the FDA using the recall number Z-2074-2026.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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