DEX Ophthalmic Tissue Forceps Field Safety Corrective Action Notice
Katalyst Surgical is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps (Model DVF4019-25-S) due to instructions for use updates. The recall affects 645 units distributed nationwide in the US and internationally.
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 medical device recall involving a field safety corrective action for instructions for use. The source text does not report any illnesses, injuries, or adverse events, and the hazard is documentation-related rather than a product defect. Per the rubric, a Class II recall without reported hospitalization or adverse events, involving instructional updates, falls in the Moderate range.
Plain-English summary
Katalyst Surgical, LLC has issued a field safety corrective action for DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number DVF4019-25-S. A total of 645 units have been affected by this action.
The corrective action involves an update to the instructions for use (IFU) for DEX Forceps and Scissors. The affected product has been distributed worldwide, including US nationwide distribution and shipments to Peru, Argentina, South Korea, Japan, and France.
The recalled devices are associated with multiple lot numbers, including M50541, M50542, M50632, M50633, M50936, M50996, M51039, M51040, M51081, M51138, M47122, M47123, M47336, M48308, M48660, M49294, M49784, M49839, M49910, M49929, M49930, M50215, M50427, M50428, and M50429, with expiration dates ranging from April 2028 through November 2028.
Users who have received these devices should contact Katalyst Surgical for the corrected instructions for use.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 645
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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