Class 2 Device Recall DEX Ophthalmic Tissue Forceps

• Date Initiated by Firm: March 25, 2026
• Date Posted: May 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2075-2026
• Recall Event ID: 98660
• Product Classification: Forceps, ophthalmic - Product Code HNR
• Product: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
• Code Information: 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
• FEI Number: 3007589150
• Recalling Firm/ Manufacturer: Katalyst Surgical, LLC; 722 Goddard Ave; Chesterfield MO 63005-1100
• For Additional Information Contact: Alex Bergoudian; +1-636-5365950
• Manufacturer Reason for Recall: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
• FDA Determined Cause: Under Investigation by firm
• Action: A Field Safety Notification: Field Safety Corrective Action for IFU in DEX Forceps and Scissors dated 3/19/26 was sent to customers. FIELD SAFETY ACTIONS REQUIRED As a customer identified in the receipt of one or more of the affected lots, you are requested/required to take the following steps: 1. Please confirm receipt of this Field Safety Notification by email, either by replying to the sender or using the email addresses listed in the signature at the bottom of this notice. 2. Review the Individualized List of Affected Lot Numbers by Customer provided in the email for lots that were distributed to your facility. Identify all of these lots that currently remain in your stock and place them on hold. 3. Provide information to Katalyst Surgical team identifying which lots are currently in stock and on hold at your facility. Katalyst Surgical will send a replacement correct IFU for each affected box. 4. Upon receipt of the correct IFU, remove the incorrect IFU, replace the correct IFU in the box, and destroy the incorrect IFU. Approval for Modification including instructions will accompany the replacement IFUs. 5. We recommend you reach out to your customers/users of these DEX products with this information. Katalyst Surgical will gladly provide correct replacement IFU documents to you for further distribution. Katalyst Surgical deeply regrets the inconvenience this causes. We assure you of our continuous support and commitment to safety and quality. Please do not hesitate to contact our team if you have any further questions.
• Quantity in Commerce: 645 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.