DEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use (IFU) related to DEX Ophthalmic Tissue Forceps (Model DVF4005-23). The corrective action addresses a labeling issue in the product instructions.
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 labeling/instructions for use issue. The source text does not report any illnesses, injuries, or deaths, and the hazard is instructional rather than a structural or functional defect of the device itself, placing it in the Moderate category.
Plain-English summary
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use in DEX Ophthalmic Tissue Forceps, specifically the 23ga DEX NanoTapered AWH Forceps (Model/Catalog Number DVF4005-23, Lot Number M50529). This is a Class II recall.
The affected product was distributed worldwide, including to the United States and the countries of Peru, Argentina, South Korea, Japan, and France. Healthcare facilities and practitioners who received this product should review the corrective action notice for updated or corrected instructions for use.
Users should contact Katalyst Surgical, LLC for the corrective action details and any guidance regarding continued use or replacement of the affected forceps.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 5
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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