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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 670
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Katalyst Surgical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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