DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall
Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.
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: The recall involves a corrective action to instructions for use, which is a documentation/labeling issue. The source text does not report any illnesses, injuries, or confirmed harms, making this a precautionary measure consistent with FDA Class II classification.
Plain-English summary
Katalyst Surgical, LLC is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number DVF4034-25. The corrective action concerns the instructions for use (IFU) for DEX Forceps and Scissors.
Approximately 750 units have been distributed worldwide, including throughout the US and to Peru, Argentina, South Korea, Japan, and France. Multiple lot numbers are affected, with expiration dates ranging from April 2028 through February 2029.
Patients and healthcare providers who have received this device should refer to the corrected instructions. For questions or more information, contact Katalyst Surgical, LLC or the FDA.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 750
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
Same manufacturer · Katalyst Surgical, LLC
See all →- ModerateDEX Ophthalmic Tissue Forceps subject to IFU corrective action
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall
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- ModerateDEX Ophthalmic Tissue Forceps Safety Corrective Action Recall
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps Require Corrective Instructions Update
FDA (Devices) · 2026-05-13
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