DEX Ophthalmic Tissue Forceps Require Corrective Instructions Update
Katalyst Surgical is correcting instructions for DEX Ophthalmic Tissue Forceps (Model DVF4022-25-S) due to a field safety issue related to the Instructions for Use (IFU).
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 addressing a labeling/instruction deficiency in a surgical device. The hazard involves potentially confusing or incomplete instructions for use rather than a device design flaw or reported injury, placing it in the Moderate category.
Plain-English summary
Katalyst Surgical, LLC is issuing a field safety corrective action for its DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps (Model/Catalog Number DVF4022-25-S). The corrective action concerns the Instructions for Use (IFU) document for the device.
Approximately 235 units have been distributed worldwide, including throughout the US and to Peru, Argentina, South Korea, Japan, and France. The affected units are identified by multiple lot numbers and expiration dates, detailed in the FDA recall notice.
Users who have received this device should consult the corrective action documentation from Katalyst Surgical, LLC, or contact the FDA for further guidance on the proper use and handling of the device until corrected instructions are provided.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
- Manufacturer
- Katalyst Surgical, LLC
- Affected units
- 235
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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