DEX Ophthalmic Tissue Forceps Safety Corrective Action Recall
Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.
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 documentation. No adverse events, injuries, or illnesses are reported in the source text, and the hazard is limited to IFU labeling rather than a defect in the device itself.
Plain-English summary
Katalyst Surgical, LLC is recalling the DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number DVF4016-25-S. The recall involves a field safety corrective action related to the instructions for use (IFU) for DEX Forceps and Scissors.
The affected product includes 90 units with various lot codes and expiration dates ranging from April 29, 2028 to November 25, 2028. The affected lot numbers are M48801, M49278, M47582, M48049, and M451038.
The product has been distributed worldwide, including throughout the United States, Peru, Argentina, South Korea, Japan, and France. Patients and healthcare providers who have received this device should consult the corrected instructions for use from the manufacturer.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 90
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 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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