DEX Ophthalmic Tissue Forceps require instructions-for-use correction
Katalyst Surgical is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.
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 to labeling/instructions for use. The source text does not report any injuries, illnesses, or adverse events. The issue is limited to documentation correction, which is a moderate-level concern.
Plain-English summary
Katalyst Surgical, LLC is issuing a field safety corrective action for the DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps (Model/Catalog Number DVF4019-27). The recall involves a correction to the instructions for use (IFU) for this device and related DEX scissors products.
The device has been distributed worldwide, including to the US and internationally to Peru, Argentina, South Korea, Japan, and France. A total of 150 units are affected across multiple lot numbers.
Customers who have received these devices should consult the corrected instructions for use provided by Katalyst Surgical, LLC. For specific lot numbers or additional information, contact the manufacturer at the contact information provided by the FDA.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 150
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
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