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).
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: 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
- Hazard
- instruction-labeling-error
Distribution
Distributed nationwide across the United States.
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