HIGH

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

Quick Facts at a Glance

Recall Date
March 25, 2026
Hazard Level
HIGH
Brand
Katalyst Surgical
Geographic Scope
1 states

Hazard Information

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Katalyst Surgical, LLC or your healthcare provider for instructions. Notification method: Letter

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Full Description

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S. Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.. Classification: Class II. Quantity: 90 units. Distribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

View Original Recall on FDA - Medical Devices

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Safety Guide

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Product Classification

Product Details

Model Numbers
Lot Code: Model No:DVF4016-25-S UDI-DI: (01)10840096205128(11)250709(17)280709(10)M48801 Lot Number: M48801 Expiration Date: 07/09/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)251010(17)281010(10)M49278 Lot Number: M49278 Expiration Date: 10/10/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)250429(17)280429(10)M47582 Lot Number: M47582 Expiration Date: 04/29/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)250527(17)280527(10)M48049 Lot Number: M48049 Expiration Date: 05/27/2028 Model No: DVF4016-25-S UDI-DI: (01)10840096205128(11)251125(17)281125(10)M51038 Lot Number: M451038 Expiration Date: 11/25/2028
Affected States
ALL
Report Date
May 13, 2026
Recall Status
ACTIVE

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DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27

Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.

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