DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Summary
The FDA issued a Class II for DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalo by Katalyst Surgical, LLC. Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors..
Details
Source
Device Recall
External ID
Z-2075-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Lot/Code Info: Lot Code: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50541 Lot Number: M50541 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50542 Lot Number: M50542 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50632 Lot Number: M50632 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50633 Lot Number: M50633 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50936 Lot Number: M50936 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50996 Lot Number: M50996 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51039 Lot Number: M51039 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51040 Lot Number: M51040 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51081 Lot Number: M51081 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251126(17)281126(10)M51138 Lot Number: M51138 Expiration Date: 11/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47122 Lot Number: M47122 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47123 Lot Number: M47123 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250429(17)280429(10)M47336 Lot Number: M47336 Expiration Date: 04/29/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250618(17)280618(10)M48308 Lot Number: M48308 Expiration Date: 06/18/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250709(17)280709(10)M48660 Lot Number: M48660 Expiration Date: 07/09/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250807(17)280807(10)M49294 Lot Number: M49294 Expiration Date: 08/07/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250819(17)280819(10)M49784 Lot Number: M49784 Expiration Date: 08/19/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49839 Lot Number: M49839 Expiration Date: 08/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49910 Lot Number: M49910 Expiration Date: 08/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250904(17)280904(0)M49929 Lot Number: M49929 Expiration Date: 09/04/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250909)17)280909(10)M49930 Lot Number: M49930 Expiration Date: 09/09/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250917(17)280917(10)M50215 Lot Number: M50215 Expiration Date: 09/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50427 Lot Number: M50427 Expiration Date: 09/24/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50429 Lot Number: M50429 Expiration Date: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50428 Lot Number: M50428 Expiration Date: 09/24/2028
Quantity Affected: 645 units
Reason for Recall
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-25
Company
Chesterfield, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Katalyst Surgical, LLC has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Katalyst Surgical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Katalyst Surgical, LLC have FDA actions?
Katalyst Surgical, LLC has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2075-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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