DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.
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 a FDA Class II recall involving a corrective action for instructions for use. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to documentation/labeling rather than a physical device defect or contamination, qualifying it as a moderate-severity recall per the rubric.
Plain-English summary
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for the DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number DVF4019-23. The recall is related to instructions for use (IFU) in DEX Forceps and Scissors.
The affected device has been distributed worldwide, including to the United States and internationally to Peru, Argentina, South Korea, Japan, and France. A total of 50 units are involved in this recall.
Affected lots include: Lot M49267 (expiration 08/07/2028), Lot M50930 (expiration 10/17/2028), Lot M51230 (expiration 11/13/2028), Lot M51587 (expiration 12/12/2028), Lot M51696 (expiration 01/15/2029), Lot M49921 (expiration 09/04/2028), and Lot M51128 (expiration 11/07/2028).
Healthcare providers and users who have received this device should contact Katalyst Surgical, LLC for further instructions regarding the corrective action for the instructions for use.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- Affected units
- 50
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
Same manufacturer · Katalyst Surgical, LLC
See all →- ModerateDEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps subject to IFU corrective action
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps Safety Corrective Action Recall
FDA (Devices) · 2026-05-13
- ModerateDEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action
FDA (Devices) · 2026-05-13
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