DEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.
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: The recall is classified by FDA as Class II, a medical device recall that does not meet the criteria for Class I. The source text does not report any injuries, illnesses, or known adverse events, nor does it specify a structural or functional defect. Per the rubric, Class II recalls without reported harm typically warrant a Moderate severity score.
Plain-English summary
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4034-27 (27-gauge stiff super grip variant). These are sterile, hand-held surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and surrounding tissues during ophthalmic surgical procedures. The devices are double-pouched in Tyvek and sold in boxes of 5.
A total of 1,330 units have been distributed worldwide, including throughout the United States and to Peru, Argentina, South Korea, Japan, and France. Multiple lot numbers are affected, with expiration dates ranging from April 2028 through January 2029.
The source material does not specify the reason for this recall or the nature of the defect or hazard. Consumers and healthcare providers in possession of affected units should contact Katalyst Surgical, LLC or the FDA for further instructions.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 1,330
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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- ModerateDEX Ophthalmic Tissue Forceps Require Corrective Instructions Update
FDA (Devices) · 2026-05-13
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