DEX Ophthalmic Tissue Forceps instructions for use correction
Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.
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 injuries or illnesses, and the hazard is related to instructional documentation rather than a device defect that poses imminent risk of serious harm.
Plain-English summary
Katalyst Surgical, LLC is issuing a field safety corrective action for instructions for use (IFU) in the DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number DVF4014-25-S. This device is used in ophthalmic surgical procedures.
A total of 80 units have been distributed worldwide, including throughout the US and to Peru, Argentina, South Korea, Japan, and France. The affected lot numbers are M49277 (expiration 09/09/2028), M47588 (expiration 05/13/2028), M47364 (expiration 05/06/2028), and M47363 (expiration 05/06/2028).
The FDA has classified this as a Class II recall. Users who have received these devices should contact Katalyst Surgical, LLC regarding the corrective action for the instructions for use.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- instruction-error
Distribution
Distributed nationwide across the United States.
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