DEX Ophthalmic Tissue Forceps subject to IFU corrective action
Katalyst Surgical is issuing a field safety corrective action for instructions for use (IFU) in DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH (Model DVF4005-25).
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: FDA Class II recall with no reported injuries or illnesses. The hazard is limited to instructions-for-use documentation deficiency, which is a non-critical safety communication issue typical of moderate-severity recalls.
Plain-English summary
Katalyst Surgical, LLC is conducting a field safety corrective action for the DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps (Model/Catalog Number DVF4005-25). The action concerns the instructions for use (IFU) for this device.
The affected product was distributed worldwide, including the US and the countries of Peru, Argentina, South Korea, Japan, and France. The recalled lot is Model No. DVF4005-25 with Lot Number M50530 and an expiration date of 09/24/2028.
Users of the affected DEX Ophthalmic Tissue Forceps should contact Katalyst Surgical, LLC for instructions on the corrective action or to obtain updated information regarding proper use of the device.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
- Manufacturer
- Katalyst Surgical, LLC
- Affected units
- 10
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 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
- ModerateDEX Ophthalmic Tissue Forceps Require Corrective Instructions Update
FDA (Devices) · 2026-05-13
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