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.
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 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
- Affected units
- 50
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 Model DVF4034-25 Instruction Recall
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps subject to IFU corrective action
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall
FDA (Devices) · 2026-05-13
- 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
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