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).
What this means for you
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
- Hazard
- instructions-for-use-deficiency
Distribution
Distributed nationwide across the United States.
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