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Recall Observatory FDA recall evidence

Device product

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

Z-2072-2026

March 25, 2026

Class II

Product summary

Firm
Katalyst Surgical, LLC
Event
Event 98660
Status
Ongoing
Classification
Class II
Quantity
90 units
Official record key
device-enforcement:Z-2072-2026

Official wording

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

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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