DEX Ophthalmic Tissue Forceps recalled for instructions update
Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.
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 for instructions-for-use. The source text does not report any illnesses, injuries, or adverse events, and the hazard is labeling/documentation related rather than a product defect that poses an immediate safety threat.
Plain-English summary
Katalyst Surgical, LLC is conducting a Field Safety Corrective Action affecting DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number DVF4034-25-S. The recall involves 50 units distributed worldwide, including US Nationwide and Peru, Argentina, South Korea, Japan, and France.
The corrective action concerns corrections to the Instructions for Use (IFU) for the DEX Forceps and Scissors. Affected lot numbers include M47337 (expiration 04/29/2028), M50921 (expiration 10/23/2028), M51525 (expiration 12/09/2028), M51526 (expiration 12/09/2028), and M52172 (expiration 02/20/2029).
Customers who have received these devices should contact Katalyst Surgical, LLC for corrected instructions and any necessary additional guidance. This is a Class II medical device recall.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- instructions-labeling
- documentation
Distribution
Distributed nationwide across the United States.
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