← FDA ENFORCEMENT
Z-2072-2026Class II

Katalyst Surgical, LLC

Recalling firm
Katalyst Surgical, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
Firm state
MO
Product quantity
90 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.