DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Summary
The FDA issued a Class II for DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping 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-2077-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Lot/Code Info: Lot Code: Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M51041 Lot Number: M51041 Expiration Date: 11/25/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250819(17)280819(10)M50093 Lot Number: M50093 Expiration Date: 08/19/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50293 Lot Number: M50293 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)250924(17)280924(10)M50216 Lot Number: M50216 Expiration Date: 09/24/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251021(17)281021(10)M50431 Lot Number: M50431 Expiration Date: 10/21/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251017(17)281017(10)M50543 Lot Number: M50543 Expiration Date: 10/17/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251023(17)281023(10)M50634 Lot Number: M50634 Expiration Date: 10/23/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251103(17)281103(10)M50903 Lot Number: M50903 Expiration Date: 11/03/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251113(17)281113(10)M50937 Lot Number: M50937 Expiration Date: 11/13/2028 Model No: DVF4022-25-S UDI-DI: (01)10840096205142(11)251125(17)281125(10)M50997 Lot Number: M50997 Expiration Date: 11/25/2028
Quantity Affected: 235 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-2077-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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